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Medical Device Manufacturer Untangles Supply Chain Issues and Addresses FDA Concerns with Help from Oriel STAT A MATRIX

Customer Challenge

Poorly designed and executed Supplier Management programs cost medical device manufacturers time and money, and they put companies at risk of receiving FDA 483s and Warning Letters — or, worse yet, they can put patients at risk.

Our customer, a manufacturer of Class II and Class III medical devices, received an FDA 483 finding that cited a weak Supplier Management system. The company was aware of this issue, but it did not have the internal resources to develop and implement the necessary corrective action. With hundreds of suppliers to manage, the growth and complexity of our customer’s supply chain had outpaced its existing Supplier Management and Quality Oversight programs.

  • This manufacturer’s Supplier Management challenges included:
  • They had too many suppliers.
  • The suppliers were spread across the globe.
  • Our customer did not have the necessary systems and metrics to understand supplier performance.
  • Some key suppliers were not performing effectively, but our customer lacked alternative sources for the components.
  • Our customer did not have enough internal resources to effectively operate its Supplier Management program.

Oriel STAT A MATRIX Approach

The company chose Oriel STAT A MATRIX to help its leadership solve these problems. The manufacturer was aware of our long, successful history working with both the FDA and other leading companies in the sector, as well as our expertise in Supplier Management, Quality System auditing, and Performance Excellence.

We sought to minimize resistance to this improvement initiative by collaborating with a number of our customer’s key suppliers from the start. Our team of consultants worked with the customer to design multiple unique supplier assessment models based on the results of criticality analyses of selected suppliers.

Factors we took into consideration included supplier past performance, contractual obligations, safety factors, and issues related to sole-source suppliers.

Solution

Oriel STAT A MATRIX conducted over 100 supplier assessments. The assessment results showed that some of the key suppliers were not performing as expected. Working with our customer and the affected suppliers, we devised unique corrective action plans to develop these suppliers and improve their performance.

In some cases, Oriel STAT A MATRIX provided consulting, training, and guidance directly to the suppliers to help remedy the deficiencies. Our consultants used a variety of methodologies to assist the suppliers in improving their existing Quality Management systems, including methodologies similar to Lean, Six Sigma, and Statistical Tools. In all cases, we emphasized the transfer of the necessary skills and knowledge to the suppliers to ensure that ownership of the processes resided with the suppliers’ employees.

Under the guidance of Oriel STAT A MATRIX’s quality and regulatory experts, our customer developed a robust Supplier Management program to address FDA concerns and satisfy international regulations. Relying on our Performance Excellence expertise, our customer was able to design a value-added program that continues to help the organization meet key business goals, including better performance, reduced costs, and improved reliability of the overall supply chain.

Benefits / Results

This supplier improvement initiative assessed more than 150 key suppliers, reviewing both Quality System effectiveness and process efficiency. These assessments empowered our customer to make business decisions — continue the relationship, terminate it, or request corrective action — based on objective information about each supplier’s performance. Our customer also gained an effective and efficient Supplier Management program to secure improvements and provide a foundation for sustainable Supplier Management.

Benefits included:

  • Developed an organizational understanding of the operational and financial impacts of poor supplier performance
  • Created an effective and efficient Supplier Management program
  • Improved product quality and availability from suppliers
  • Minimized supply chain disruptions
  • Improved supplier performance
  • Reduced the number of suppliers and cut supply chain costs
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