Buch, Englisch, 294 Seiten, Format (B × H): 191 mm x 233 mm, Gewicht: 615 g
Strategy and Techniques for Improving Efficiency and Effectiveness
Buch, Englisch, 294 Seiten, Format (B × H): 191 mm x 233 mm, Gewicht: 615 g
ISBN: 978-0-12-814221-9
Verlag: Elsevier Science Publishing Co Inc
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
Part 1: An Effective Quality System1. Regulatory requirements 2. Increasing Expectations3. Establish and Maintain4. QMS Structure
Part 2: An Efficient Quality Management System5. Shifting from Cost of Quality to Value of Quality6. Avoiding Common mistakes
Part 3: Roles, Responsibilities, Capabilities7. Quality is Not an Organization8. Roles: Management Representative9. Management with Executive Responsibility10. Process Ownership11. Capabilities:Measure - Metrics and DashboardsEmbrace- Culture and ValueIdentify - Inspection, Audit, Process Control, etc.Fix - CAPA, Six Sigma, and morePrioritize - Risk Management, Residual RiskControl - Monitor and ControlShare and Communicate - Management Review and Transparency
Part 4: Quality Leadership and a Seat at the Table12. Value of Quality13. Maturity Modeling in Medical Device Companies
Part 5: Vision, Strategy, Quality Planning14. Compelling Vision15. Alignment16. Translating vision to plans
Part 6: Improvement: Tools and Techniques17. CAPA18. Six Sigma