CAPA (CORRECTIVE AND PREVENTATIVE ACTION)

One day course

Key Objectives:

• To learn tools and techniques to be able to apply improve to process and document corrective and preventative action
• How to address audit/ inspection findings using CAPA and process improvement
• To understand how to make existing processes more efficient and compliant
• To look at process improvement options
• To diagnose process inefficiencies
• To consider implementation options

PROGRAMME

Introduction and Objectives

CAPA Methodology and Documentation

• Identification – clearly define the problem
• Evaluation – appraise the magnitude and impact eg scenarios, test out assumptions (eg using the Uncertainty – Importance grid to 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 eg Stakholder 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)