Length: 2 Days
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RCA in Medical Device Manufacturing Workshop by Tonex

This workshop focuses on Root Cause Analysis (RCA) techniques specifically tailored for the medical device manufacturing industry. Participants will learn to identify, analyze, and mitigate failures in medical device production to ensure compliance, safety, and reliability. The course integrates industry best practices with real-world case studies to provide a comprehensive understanding of RCA processes.

Learning Objectives

  • Understand the principles and methods of Root Cause Analysis.
  • Apply RCA techniques to identify underlying causes of failures in medical device manufacturing.
  • Develop corrective and preventive actions to mitigate risks.
  • Ensure compliance with industry regulations and standards.
  • Enhance problem-solving skills specific to medical device manufacturing.
  • Implement RCA tools and techniques in real-world scenarios.

Audience

  • Quality Assurance Managers
  • Manufacturing Engineers
  • Regulatory Compliance Professionals
  • Production Supervisors
  • Process Improvement Specialists
  • Medical Device Designers

Program Modules

  1. Introduction to Root Cause Analysis (RCA)
    • Definition and Importance of RCA
    • Overview of RCA Tools and Techniques
    • RCA in the Context of Medical Device Manufacturing
    • Key Concepts and Terminology
    • Regulatory Requirements
    • Benefits of Effective RCA
  2. RCA Methodologies
    • Fishbone Diagram (Ishikawa)
    • 5 Whys Analysis
    • Failure Mode and Effects Analysis (FMEA)
    • Fault Tree Analysis (FTA)
    • Pareto Analysis
    • Barrier Analysis
  3. Data Collection and Analysis
    • Data Gathering Techniques
    • Identifying Relevant Data Sources
    • Statistical Analysis Tools
    • Root Cause Identification
    • Case Studies and Examples
    • Practical Exercises
  4. Developing Corrective and Preventive Actions (CAPA)
    • Formulating Effective CAPA Plans
    • Implementation Strategies
    • Monitoring and Verification
    • Documentation and Reporting
    • Risk Management
    • Continuous Improvement
  5. Regulatory Compliance and Standards
    • FDA Requirements for Medical Devices
    • ISO 13485 and ISO 14971
    • Global Regulatory Frameworks
    • Documentation and Record-Keeping
    • Audits and Inspections
    • Case Studies on Regulatory Compliance
  6. Practical Application of RCA
    • Real-World Scenarios
    • Group Exercises and Workshops
    • Role-Playing Activities
    • Simulation of RCA Processes
    • Interactive Q&A Sessions
    • Project Presentation and Feedback

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