Bass Masri's Blog
Quality by Design
- Quality by design was a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design.
- In an industry-government partnership, the FDA, along with support from industry, launched a Quality by Design (QbD) initiative to help streamline the product development and approval process.
- Statistical methods such as measurement systems analysis, hypothesis testing, designed experiments, process capability analysis and sampling plans play an important and integral role in QbD.
- In this Quality By Design - Community Post, we learn how to build in quality, design efficient processes and manufacture high-quality pharmaceuticals and medical devices.
Agenda Items
Quality by Design is an industry-wide framework with a focus on planning quality into product and process design and validating using statistical methods...
- Measurement Systems Analysis
- Distribution Analysis and Hypothesis Testing
- Statistical Process Control and Process Capability
- Predictive Models and Design of Experiments
- Acceptance Sampling Plans *
Case Study
Situation: You are the new product introductions manager responsible for new tablet production and validating the manufacturing process.
Task: You establish by objective evidence that the manufacturing process can consistently produce tablets that meet specifications.
Action: Use measurement systems, hypothesis testing, process control, designed experiments and predictive models to optimize production.
Results: Identify the factors that most significantly affect the response, recommend improvements and optimize to achieve the highest yield.
Next Steps: Your study findings are shared with colleagues in other facilities, which lead to process improvements and efficiencies globally.
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