What is Quality Culture?
- Why the focus on Quality Culture?
- Why is it important?
- Who creates culture and how?
- Core elements
- Leadership at the top
- Confidence in the part of all employees
- Clear management visibility and leadership
- Accountability at all levels
- Sharing of knowledge and information
- Best practices
- Before you improve the Quality Culture
- Understand why changing culture is hard
- What must be influenced to see desirable changes
Developing a Quality Culture; why is EU GMP Volume 4 Chapters 1-9 the wrong Place to start?
- How does EU-GMP promote a Quality Culture?
- What kind of Quality Culture does Chapter 1 promote?
- Where can we look to for better Quality Culture Guidance?
- Looking to the great Quality Culture proponents (ISO 9001, Deming, Motorola, Toyota) for inspiration
- Which Quality Culture Options should be implemented in Business?
Knowledge Management and Knowledge Structuring
- Principles – definition and segregation
- Knowledge Management as part of Quality Culture
- From content to knowledge: structuring of knowledge
- Semantic Web: Ontology vs. Topic Map
- Relationship models and retrieval - how does knowledge become available
- Knowledge Management and Data Integrity
- How do I keep knowledge up-to-date? Knowledge Management Systems (KMS) vs. Data Warehouse
- Practice example: How can I store and preserve knowledge in a structured storage format?
Case Study: Boehringer Ingelheim’s Quality Culture Initiative
- Cultural enablement as a foundation for CQI und Business Continuity
- Quality Culture at BI: From initiative introduction to operationalisation
- Dimensions of cultural excellence framework
- Is Quality Culture measurable?
Interactive Sessions on:
Quality Control Laboratory
- Indicate/identify “bad” quality culture behaviours
- How to get to a better quality culture (how to create new behaviour)
- What will happen if we do not take the right action
- Set up appropriate KPIs
Techniques to evaluate Quality Performance
- Process Analysis
- Root Cause Analysis
- Cause-and-Effect Diagrams
- Risk Assessment
- Quality Cockpit
- Tracking & Trending
Error culture as part of Quality Culture
- How mistakes / errors become disasters
- Root Causes (Deep Dives) - symptoms and effects
- Good error culture: from error to success
- Errors and mistakes in the workspace: practical examples
- Role of the executive management - dealing with mistakes
- Tools from the OPEX toolbox
- Cooperation instead of confrontation
- The toddler rule: action must have consequences
- The team spirit
A Behavior-Based Continuous Improvement Model
- Creating Quality Culture performance expectations
- Educating and training to influence behavior
- Communicating Quality Culture effectively
- Developing Quality Culture goals and measurements
- Using consequences to increase or decrease behaviors
- Encourage & energize the team