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