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Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive quality culture. This course will also discuss the latest draft guidance from the FDA in regards to quality metrics.


Part 1 – Establishing appropriate quality metrics

  • Understand why metrics are important to both individuals and management
  • Understand the difference between Key Performance Indicators (KPIs) and metrics
  • Review common quality metrics and the associated mathematical equations
  • Discuss the use of dashboards
  • Discuss common errors associated with establishing metrics

Part 2 – Driving Quality Culture through appropriate Quality Metrics

  • Understand that what gets measured will directly impact employee behaviors
  • Discuss how to ensure Quality metrics that will result in the behaviors you want
  • Discuss how to utilize Quality metrics to improve both individual and company performance

Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics

  • Review the contents of the FDA guidance on Quality Metrics

This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive quality culture, and the course will also discuss the latest draft guidance from the FDA in regards to quality metrics.


Part 1 – Establishing Appropriate Quality Metrics

   In this section, we will understand and discuss:

  • Why metrics are important to both individuals and management?
  • The difference between Key Performance Indicators (KPIs) and metrics
  • Review common quality metrics and the associated mathematical equations
  • The use of dashboards
  • Common errors associated with establishing metrics

Part 2 – Driving Quality Culture through appropriate Quality Metrics

   In this section, we will understand and discuss:

  • What gets measured will directly impact employee behaviors
  • How to ensure quality metrics will result in the behaviors you want?
  • How to utilize quality metrics to improve both individual and company performance?

Part 3 – Discuss the 2016 Draft Guidance from the FDA on Quality Metrics

  • We will review the contents of the FDA guidance on quality metrics.

  • Research and Development departments
  • Quality departments
  • Manufacturing departments
  • Engineering departments
  • Operations departments
  • Regulatory Affairs departments

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

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