Supplier Risk & Relationship Management in FDA

Situation

• The medical device company was experiencing a need to become more compliant with the FDA regulations regarding supplier control and monitoring
• There was a need to examine their current processes to ensure and to create tighter controls around supplier risk assessments, scorecards and business reviews

Goal

• To develop the tools and assessments in order to assist in risk awareness and mitigation and to further develop supplier communication tools
• To develop supplier management communication tool

Approach

• Created a Quality and Compliance Risk Assessment based on a variety of attributes and parameters for all Suppliers and their respective components
• Developed a Business Continuity Risk Assessment that measures the organization’s risk to a supplier/components
• Customized a standardized business review process that incorporates the quality, business and technical performance areas
• Provided a method to track a supplier’s performance internally and externally in delivery, financial and quality

Results

• A technological solution for the two risk assessments, which automates the data, calculaitons and allows for flexibility in reporting
• An automated scorecard for internal use and is automatically available for supplier’s review and updates
• A standardized business review template that incorporates performance, state of the business, project management and 360 degree reviews