Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

The right quality metrics do more than report on the health of your quality system. They shape behavior, build quality culture and improve individual and company performance.

This 90-minute quality metrics and KPIs training explains why metrics matter to individuals and management, how key performance indicators differ from other metrics, and the common quality measures and the equations behind them. You'll also see how to use dashboards and avoid the usual mistakes when setting up metrics.

Because what gets measured changes how people act, the session shows how to design metrics that produce the behaviors you want. It ends with a review of FDA's 2016 draft guidance on quality metrics.

• Explain why quality metrics matter to individuals and management
• Distinguish KPIs from other metrics
• Calculate common quality metrics
• Use dashboards and avoid common metric errors
• Design metrics that drive the behaviors and quality culture you want
• Summarize FDA's 2016 draft guidance on quality metrics

Establishing appropriate quality metrics

• Why metrics matter to individuals and management
• The difference between KPIs and metrics
• Common quality metrics and their equations
• Using dashboards
• Common errors when establishing metrics

Driving quality culture through metrics

• How what gets measured affects employee behavior
• Making sure metrics produce the behaviors you want
• Using metrics to improve individual and company performance

FDA draft guidance

• The contents of FDA's 2016 draft guidance on quality metrics

Poorly chosen metrics can push people toward the wrong behaviors, while well-chosen ones improve performance and quality culture. This session helps you set metrics that measure what matters.

It suits regulatory affairs professionals, quality managers and quality engineers who set or report quality metrics and need to understand FDA's thinking on them.

• Regulatory Affairs professionals
• Quality Managers
• Quality Engineers

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.