At the Q1 11th Annual Medical Device Supplier Quality Assurance Conference, Sparta’s Zillery Fortner presented her topic “How to Establish Supplier Qualifications.”

This conference was a forum to deliver a first-in-class educational and networking platform for supplier professionals. The 2-day event focused on strategies to align compliance, utilizing a risk-based approach, system management, maintaining supply chain control and fostering collaborative supplier relationships. 

Fortner’s session provided attendees with the overall knowledge and resources needed to build supplier qualifications. 

We’ve rounded up some of the insights and practical takeaways from Fortner’s Q&A session below:

Q: How are quality agreements best incorporated into supply chain management and how often should they be reviewed? What measures should be in place when deficiencies are found?

A: Quality agreements are a tricky subject.  Using a risk assessment approach, determine if the agreements are applicable and what frequency they should be reviewed.  Quality agreements should not be cut and paste; they need to be tailored to each customer containing at a minimum: 

  • Appropriate written responsibilities for cGMP activities 
  • Purpose/scope 
  • Product/service(s) 
  • Contact information 
  • Terms and expirations 
  • Quality control, change control, change management 
  • Dispute resolution 
  • Regulatory compliance 
  • Reporting support 

During the supplier review, take time to go through the quality agreement providing both parties expectations.  Ensure both parties have a point of contact, providing a streamlined system for communication.  Maintain supplier agreements per your retention policy. 

Q: Where would you draw the line between software suppliers that need to be on your approved supplier list and ones that don’t? We are going through this exercise now. There are many debates between who should be in scope and monitored versus well-known sources that wouldn’t pose any risk or take time to complete any customer qualification paperwork.

A: The first step would be to review what services and support apply to the software.  Then ask them, “what if”?  What if this happened, or what if the label was printed wrong?  Document this process.  Then if the software does not affect parts of the quality management system (QMS), they would not be included on the approved supplier list (ASL).  The documentation would be your risk overview.  But let’s say component numbers were transferred from the software to XYZ system to build a product, then you would evaluate just that section and add just that section to the ASL.

Q: I haven’t seen a supplier tier system described the way it was in this presentation. Do others use a similar approach and incorporate volume/spend into these designations for suppliers?

A: When COVID-19 hit, I quickly learned that we had a significant disconnect with our supply chain. Like most companies, we did not understand supplier risk and inventory.  Using a “holistic” approach to supplier management and implementing a tier classification system will allow companies to be proactive with their suppliers, showing customers that their products/services are safe and reliable.  When supplier systems are siloed, there is no flexibility or resilience.  Moving towards a robust Supply Chain 4.0 system will allow for continuous monitoring, efficiency and reduced cost. It will also provide real-time information, and enable you to identify external factors that influence your business.    

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