Process Development & Improvement

To apply Quality by Design and process design & improvement strategies effectively, thorough understanding of available tools and possibilities is required. Although overall principles are often known, practical execution may be challenging. Good design practice will undoubtly provide significant benefits in the areas of process risks, yield and quality. In addition, the current regulatory landscape increasingly demands in-depth knowledge and risk-based validation of processes. InProcess-LSP has broad expertise (black belt level) both in Six Sigma based improvement (DMAIC) and design (IDOV) projects, and in applying Quality by Design in process development. Our process development and improvement services typically include:

  • QbD strategy and filing support
  • Risk Assessment strategy support and facilitation
  • Six Sigma based design and improvement projects
  • Design of Experiments support
  • (Monte Carlo) Simulation
  • Process performance evaluation and statistics