Two days workshop on
Supplier Management for Medical Device Manufacturers
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that the suppliers may be critical to both device performance and on-time delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you, the device manufacturer, to implement an effective process for supplier management and performance.

The workshop covers the regulatory requirements from FDA's QSR, ISO 13485:2003, ISO 13485:2016, and the EU variants.This two-day hands-on workshop delivers the tools, templates, and methods to help implement an effective, efficient, and compliant supplier management program.The workshop provides a clear explanation of the underlying principles of supplier management and uses exercises to help solidify understanding. The workshop uses FDA Warning Letters to illustrate the points and provide an opportunity to avoid similar implementation problems. As part of the practical implementation theme, the course includes receiving acceptance activities, outsourced processes, supplier's process validation, supplier auditing techniques, and supplier issues in management review.

Supplier management is a process. The workshop uses the Global Harmonization Task Force (GHTF) guidance document, but expands it to include issues and techniques important in effective implementation.The workshop material includes discussion topics, multiple exercises, guidance documents, and templates/tools to help implement an effective program.

Learning Objectives
  • Understand FDA QSR, ISO 13485:2003, and ISO 13485:2016 requirements for supplier management
  • Understand the FDA's multitier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Use an analysis matrix and radar chart to compare suppliers
  • Explain the link between design control and purchasing data
  • Develop an overall supplier management plan
  • Understand how to develop and implement supplier controls
  • Create receiving inspection criteria and use them as part of supplier controls
  • Develop supplier measurement and monitoring systems
  • Understand the three application of risk management: business risk, regulatory risk, and medical device risk
  • Learn how to determine when to audit a supplier and the audit's scope
  • Developing a supplier audit using the backward trace process approach
Who can Benefit
  • Quality Managers
  • Supply Chain Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Purchasing Professionals
  • Regulatory Specialists
  • Production and Process Engineers
  • Design and Development Engineers
  • Verification and Validation Specialists
Agenda

Day 1 (8:30 am – 9:00 am: Registration Process)

Part A - Regulatory Requirements
  • Supplier management in FDA QSR, ISO 13485:2003, & ISO 13485:2016
  • EU Medical Device Directive (MDD)
    • Unannounced visits
  • Supplier Evaluation and Selection
    • When suppliers have to register and list with FDA
    • Outsourced processes
  • Purchasing Data
  • Acceptance activities
Part B - Planning for Supplier Management
  • Supplier management as a business process
  • The business risk model
  • The regulatory risk model
  • The medical device risk model
Part C - Planning for Supplier Selection
  • Identifying what to procure
  • Design control and purchasing data
  • Identify risks (business, regulatory, and device)
  • Identify controls (business, regulatory, and device)
  • Special considerations
    • UDI
    • Control numbers
    • RoHS
    • Conflict Minerals
Part D - Potential Suppliers
  • Identify potential suppliers
  • Evaluative business capability
  • Evaluate operational capability
  • Using an analysis matrix and a radar chart
Day 2 (9:00 am : Workshop Start)

Part E - Supplier Selection
  • Sole source v. single source
  • The directed procurement problem
  • Selecting the supplier
  • The Approved Supplier List
Part F - Implementing Supplier Controls
  • Building the final control plan
  • Receiving acceptance as a supplier control
  • Developing hidden controls
  • The supplier quality agreement
Part G - Monitoring, Measuring, and Evaluation
  • Standard supplier metrics
  • Implementing predictive analysis
  • Developing a supplier audit program
  • Using the supplier's QMS certificate
  • The backward tracing process audit
  • Supplier management as part of Management Review
Part H - Feedback and Communication
  • Supplier scorecards
  • Corrective action requests
Part I - Evaluating your program
  • Maturity models for supplier management
  • FDA's QSIT
  • GHTF guidance on auditing supplier control

Daniel O'Leary - President, Ombu Enterprises, LLC


Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.