Goal

Empower professionals to effectively analyze and solve problems - with unrepeated problems, and in compliance with regulatory and Quality Management System requirements

Methodology

Exposure and contextualization of content, and creation, analysis, conduction and discussion of scenarios for application - through case studies of the organization.

Content

I - Concepts and Foundations
  • Problem or Nonconformity?
  • Action Types: Corrective, Preventive, Containment, Correction
  • Root Cause, Nearby Causes, and Potential Causes
  • Relationship between Actions and Management Systems
  • 5W3H Plans
  • Risk based thinking
II – Method
  • Problem description
  • Time Definition
  • Comprehensive Analysis
  • Containment and Correction Actions
  • Cause Analysis and Root Cause Definition
  • Corrective actions
  • Effectiveness Check and Lessons Learned
III – Root Cause Analysis Techniques
  • Questioning Practices
  • Cause and Effect Diagram
  • 5 Why Analysis
  • Methods and Techniques Integration

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Regulatory Framework