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YOUR COMPANY’S
QUALITY CULTURE
PRESENTED BY
R. Kieffer
References
R. Kieffer
REGULATORY CULTURE
R. Kieffer
Problems with Regulatory Culture
1. Confusion
R. Kieffer
Problems with Regulatory Culture
R. Kieffer
Problems with Regulatory Culture
• Frequently takes responsibility for tasks that they do not have the capability
to perform and which rightly should be performed by other departments.
(investigations of failures, writing of SOPs, validation……….)
• Modern Role of QU
- Process improver - design of effective and efficient processes
- Quality promotor – recognize superior performance
- Quality expert – look outside of the pharmaceutical industry for best practices
R. Kieffer
Process Improver:
• Production
• Validation
• Training
R. Kieffer
Quality Promotor:
R. Kieffer
Problems with Regulatory Culture
4. Continuous Improvement
R. Kieffer
Problems with Regulatory Culture
R. Kieffer
Role of Senior Management
R. Kieffer
Role of Senior Management
Requirements:
• Training
• Plan
• Time
• Action
R. Kieffer
Role of Senior Management – Walking the Talk
R. Kieffer
Role of Senior Management – Walking the Talk
Implementation
R. Kieffer
Role of Senior Management – Walking the Talk
Time Investment:
• every employee 2-3 days/year
• managers 6-8 days/year
R. Kieffer
FOR THINGS TO CHANGE,
I MUST CHANGE
R. Kieffer