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ISO 13485 Advanced Quality Planning Training

ISO 13485:2003 Advanced Quality Planning and Disciplined Phase Approach to New Product Development

Seminar Content

This one-day hands-on seminar is intended to equip participants with the skills required to succeed in the application of Advanced Quality Planning (AQP) to the product realization and Supplier Quality Management (SQM) process. The approach of this course is based on best practices by experts in the field.

By attending this course, participants will also gain insight and knowledge regarding the use of prevention-based techniques used for an on-time and low PPM product launch. These techniques include Project Planning, Project Reviews, Risk Analysis and Manufacturing Feasibility Risk Analysis, as well as conducting Project Reviews and planning for overall Project Reviews and Project Scorecards. The use of risk-based and FMEA-based processes, including an enhanced FAI/AQP process currently used by companies in the Medical Devices industry such as Stryker, Abbott Laboratories and TeraRecon will be discussed.

This class includes breakout exercise sessions using an example of a Medical Device sub-assembly project and product launch. This running example will be used throughout the five-day Risk Management and Analysis in Medical Device Manufacturing Series.

Who Should Attend

  • Project Managers
  • FMEA Facilitators
  • All other Risk Management personnel

Recommended Training and/or Experience

Participants should possess a working knowledge of quality systems and methodologies.

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Seminar Goals

  • Understand standardized terminology for AQP
  • Gain insight, knowledge and skill sets required for AQP and Risk Management, including:
    • Project Planning
    • Risk Analysis
    • Project Reviews
  • Understand the standardized approach for the AQP and best-in-class techniques

Seminar Outline

  • Overview: Advanced Quality Planning and Project Management
  • The Need for Change
  • Industry in Transition
  • Project Management
  • Advanced Quality Planning
    • Breakout Exercise: Phase 1 Project Planning – Part A
  • Risk Analysis
    • Breakout Exercise: Phase 1 Project Planning – Part B
  • Project Timing
    • Breakout Exercise: Phase 1 Project Planning – Part C
  • Conducting the Project Kick Off
    • Breakout Exercise: Update the Project Plan
  • AQP Project Reviews
    • Breakout Exercise: Project Review Agenda and
  • Project Scorecards
  • Conducting a Design Review
    • Breakout Exercise: Discussion on Design Review

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