Improving Processes and Capa (Corrective and Preventative Action)

• CAPA Methodology and Documentation*
• Identification – clearly define the problem
• Evaluation – appraise the magnitude and impact, e.g. scenCAPA Methodology and Documentation
• Identification – clearly define the problem
• Evaluation – appraise the magnitude and impact, e.g. scenarios, test out assumptions and help identify potential risks
• Investigation
• Analysis – perform a thorough assessment
  • review data, prioritise, develop options for solutions
• Action Plan – create a list of required tasks
• Implementation – execute the action plan, e.g. stakeholder analysis, the transition curve
• Follow Up – verify and assess the effectiveness of the CAPA
• Finding(s)

Diagnosing Process Improvement

• Using problem diagnosis (for example, “root cause” analysis) for understanding why processes are cumbersome and to help facilitate resolving audit and inspection findings

Developing Options for Process Improvement and CAPA

• Being more creative in problem solving of process simplification issues
• Evaluation of the attractiveness/likely difficulty of changes (“AID” analysis)
• Continuous improvement teams – as an invaluable approach for improving the implementation of regulatory change

Planning and Implementation in Practice of Improvements and CAPA

• Project managing process improvements and CAPA
• Managing the change and people issues
• Managing the stakeholders involved (stakeholder analysis)

Final Discussion