Quality Metrics and beyond
- Expectations of the agencies
- Quality Culture as the basis for quality improvements
- How to involve the management in Quality Metrics
- Set up of a practical review system
- Follow up actions on management reviews
FDA’s Quality Metrics Program
- What is the status of the FDA Quality Metrics Program?
- The new Quality Metrics Feedback Program and Quality Metrics Site Visit Program
- Case Study: Experience with the FDA Quality Metrics Pilot Phase
Integration of Quality Metrics Systems and KPIs in Continuous Improvement and Business Continuity
- Understanding critical processes & where quality risks lie/ process mapping
- Defining the right KPIs
- Meaningful metrics (and the pitfalls)
- The role of Quality Impact Assessment & effectiveness checks
- The link to Opportunities for Improvement (OFIs), Continuous Quality Improvements (CQIs) and Business Continuity
Psychological Aspects of Continuous Improvement
- What do the numbers tell us?
- Business culture
- Empowerment of people
Assignment of Metrics and Correlation with Process Controls
- The importance of proper use and relevance of lagging and leading KPIs in correlation with process controls.
- The set up and implementation of a risk based data evaluation methods for continual improvement and the Management Review
KPIs and the Cost of Non-Conformance
- Quality by the numbers: what are quality costs?
- How to determine the cost of poor quality
- Quantify – analyse - improve
- Calculating return on investment
Case Study: Quality Metrics as a Key Driver for CQI
- Why did we implement Metrics?
- How did we do it?
- What was the outcome?
- Lessons learned
- How to apply Quality Metrics as a Key Driver for CQI
Parallel sessions (2 out of 3)
1. Managing Data: The Bridge from Quality Metrics to CQI
- Defining the right KPIs and Meaningful metrics (work on examples)
- What to learn from the data
2. Quality Metrics Principles to foster Business Continuity
- Expectations of authorities, what is essential for performance metrics?
- The link to ICH Q12: Quality Metrics as part of Product Lifecycle Management.
- Case Study: Continual risk mitigation to transform lagging performance data into Leading Metrics and Quality Objectives
3. Analysis Tools for assessing and optimising Process Flows
- How to choose and use the correct tools
You will be able to attend 2 of these sessions. Please choose the ones you like to attend when you register for the course.
Wrap-up: What the Future will bring
- True understanding of the quality risks specific to our businesses
- A shift to pro-active QRM from reactive risk assessment
- Integration of QRM and change management
- Moving away from the functional silo mentality
- Process and QMS improvement in the interest of patient care
- Meaningful performance evaluation criteria and metrics