Six Sigma in Industrial Pharmacy

Questions and Answers

To ensure that gains made during the Improve phase are held

To prove the effectiveness of the solution

Creating a focus on customers and building customer loyalty

To identify barriers and aids to the solution Signup and view all the answers

To ensure that the process is in control Signup and view all the answers

To prove the effectiveness of the solution Signup and view all the answers

A pragmatic way to achieve greater levels of process quality Signup and view all the answers

To compare different solutions Signup and view all the answers

To generate alternative solutions and design the solution Signup and view all the answers

To identify best practices Signup and view all the answers

Study Notes

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

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)

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:
- 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

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

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

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