Podcast
Questions and Answers
What is the primary goal of the Control phase in the DMAIC methodology?
What is the primary goal of the Control phase in the DMAIC methodology?
What is the purpose of the Pilot Study tool in the Improve phase?
What is the purpose of the Pilot Study tool in the Improve phase?
What is the outcome of applying Lean Six Sigma DMAIC methodology according to the text?
What is the outcome of applying Lean Six Sigma DMAIC methodology according to the text?
What is the purpose of the Barriers and Aids Chart tool in the Improve phase?
What is the purpose of the Barriers and Aids Chart tool in the Improve phase?
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What is the role of the Process Control Plan in the Control phase?
What is the role of the Process Control Plan in the Control phase?
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What is the primary goal of the Improve phase in the DMAIC methodology?
What is the primary goal of the Improve phase in the DMAIC methodology?
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What is the outcome of creating a quality culture according to the text?
What is the outcome of creating a quality culture according to the text?
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What is the purpose of the Pugh Matrix tool in the Improve phase?
What is the purpose of the Pugh Matrix tool in the Improve phase?
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What is the role of the team in the Improve phase?
What is the role of the team in the Improve phase?
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What is the purpose of the Benchmarking tool in the Improve phase?
What is the purpose of the Benchmarking tool in the Improve phase?
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Study Notes
Dimensions of Pharmaceutical Quality for the 21st Century
- FDA initiatives:
- cGMP (Current Good Manufacturing Practice)
- PAT (Process Analytical Technology)
- ICH (International Conference on Harmonisation)
- Quality tools:
- TQM (Total Quality Management)
- Six Sigma
- Fusion Management
What is Six Sigma?
- A strategy to improve process quality by identifying and eliminating defects and minimizing variation in process outputs
- A data-driven approach based on measurement of process variation using Statistical Process Control (SPC)
Comparison of TQM and Six Sigma
- TQM:
- Solid tools but vague goals
- No standard metrics
- Open-ended, unstructured
- Department-based
- Focus on product quality
- Six Sigma:
- Real results that matter to customers
- Business tool
- Clear, consistent metrics
- Business-based
- Focus on customer
Six Sigma Levels
- Defect: any process output that does not meet customer specifications
- Goals:
- Reduce process variation
- Improve quality by reducing defects per million opportunities (DPMO)
- Two attributes to control:
- Opportunities
- Defects
Three Sigma vs Six Sigma
- Three Sigma:
- 99% good
- 20,000 lost articles of mail per hour
- Unsafe drinking water for almost 15 minutes per day
- Six Sigma:
- 99.99966% good
- Seven articles of mail lost per hour
- One unsafe minute every seven months
Case Study 1: Monitoring Doses of White Bean Medicine
- Pharmaceutical application of Six Sigma
- Monitoring dosages using control charts
- Process improvements made as needed based on data collected
Six Sigma Process - DMAIC
- Define:
- Identify key characteristics important to the customer
- Establish project goals and objectives
- Measure:
- Collect data and establish baseline performance
- Verify measurement systems
- Analyze:
- Convert raw data into information
- Identify root causes of problems
- Improve:
- Develop solutions to improve process capability
- Compare results to baseline performance
- Control:
- Monitor the process to assure no unexpected changes occur
Tools for DMAIC Phases
- Define:
- Stakeholder analysis
- Voice of the customer
- High-level process map (SIPOC diagram)
- Measure:
- Juran's Pareto Analysis
- Data Collection Plan
- Detailed Process Mapping
- 6S
- Value Stream Maps
- Analyze:
- Calculating Sigma Level
- Graphs and Charts
- Brainstorming
- Stratification
- Histograms
- Box Plots
- Scatter Diagrams
- Cause and Effect Diagrams
- 5 Why Analysis
- Failure Mode and Effect Analysis
- Impact Control Matrix
- Improve:
- Brainstorming
- Solution Matrix
- Barriers and Aids Chart
- Pilot Study
- Mistake Proofing
- Benchmarking
- Pugh Matrix
- Control:
- Process Control Plan
- Control Charts
Impact of Lean Six Sigma DMAIC Methodology
- Ensuring quality thinking becomes the way of doing business
- Applying proven quality tools to improve goods and services
- Defining quality process performance metrics that tie to organizational goals
- Creating a quality culture that is fun and provides a pragmatic way to achieve greater levels of process quality
- Identifying projects to drive improvement and achieve superior quality and sustainable results
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Description
Learn about Six Sigma, a data-driven approach to improve process quality in industrial pharmacy, and its relation to FDA initiatives, quality tools, and pharmaceutical quality.
