Supplier Quality

We consider our suppliers a key partner in our pursuit of quality for our customers, and the patients who depend on our products and therapies. We can never be content with what we achieved last year, last quarter, or even yesterday. That's why we're training our key suppliers on the importance of quality to our products and the patients who use them.

Production and process control

MiniMed expects suppliers to develop and maintain highly capable processes that produce quality Products and Services. We expect suppliers to have systems in place that define and maintain manufacturing processes to ensure that products conforms to the specifications.

Your role as a supplier 

Collaborate with us to understand how design requirements influence manufacturability and identify improvements to reduce risks. Work with us to develop process control plans and embed them as a standard part of your quality system. Ensure control plans identify critical features of processes and repeatable methods to measure and monitor them.

Change control

We recognize that continuous improvement efforts may require changes to manage cost, quality, delivery, and technology. However, implementation of unapproved changes can have unintended effects on our products and therapies, our operations and, more importantly, our customers and patients. Suppliers must notify MiniMed of changes made to materials, products, or processes. 

Your role as a supplier 

  • Provide adequate advance notification of the change by submitting a request through the Supplier Change Request.
  • Define a proactive process to identify and manage changes from sub-tier suppliers.

Supplier benefits

  • Standardized submission process for all changes within MiniMed
  • Standard web form and content requirements to submit change request
  • Visibility and notification of status updates across all MiniMed sites
  • Traceability to submitted changes

Easy steps for suppliers

1. Log in to website

  • First time users need to create an account
  • You can manage and reset your own password.

2. Complete Supplier Change Request (SCR) and submit.

3. SCR team may follow-up with supplier.

4. Monitor status — you will receive email notifications for the following;

  1. Reminders of items in draft status
  2. Receipt of original request
  3. Status updates
  4. If needed, request for more information
  5. Approval or disapproval of change and close notice, when last facility completes review

 Troubleshooting steps for issues with error message in the SCR portal:

  1. Use Chrome as browser
  2. Clear cache and cookies, then re-launch browser
  3. Access the SCR portal 
  4. Log back in using registered email and password

5.      Go to Supplier Change Request portal self help guide or contact rs.changeportalhelp@medtronic.com.

Sub-tier selection and management

Suppliers are expected to manage sub-tier suppliers to ensure that Product(s) manufactured utilize only specified material and meet all requirements of the Specification. 

Your role as a supplier 

Make supplier management an active part of your quality system. Identify and mitigate risks that sub-tier suppliers pose to finished products. Manage sub-tier supplier changes and notify MiniMed as applicable.

Risk management

We expect our suppliers to have a robust risk management process to identify, prioritize and mitigate risks. The risk management process should include a business continuity plan to facilitate rapid response and recovery in the event of disruptions. 

Your role as a supplier 

Formalize a risk mitigation strategy within your business for MiniMed or MiniMed products. Collaborate with us to proactively address and eliminate or minimize risks identified. 

Auditing

MiniMed may choose to audit the supplier or sub-tier supplier’s manufacturing and Quality Systems to ensure compliance to quality requirements. 

Your role as a supplier 

Provide access to your facility and focused support for the duration of the audit. Provide timely response to all findings and implement corrective and preventive actions where applicable.

Corrective and Preventive Actions (CAPA)

Suppliers are expected to establish and maintain a Corrective and Preventive Action (CAPA) process. 

Your role as a supplier 

Engage in timely resolution when action is required. Conduct robust investigation and root cause analysis to identify actions to correct and prevent reoccurrence. Verify the actions taken were effective and did not adversely affect the product or service.

Design and development innovation

Continuous innovation is critical for us to continue fulfilling our mission. But innovation isn’t limited to big medical breakthroughs. A revolutionary new way to tool a part is just as important in improving our products.

We work closely with suppliers to improve the design, reliability, and manufacturability (DRM) of our components and products.

We expect all our suppliers to:

  • Be active and dedicated throughout the entire process
  • Be open to changes
  • Look for ways to continuously improve in all aspects of their company

Standard product qualification | PPAP

MiniMed has adopted a time-tested approach to supplier component qualifications called Production Part Approval Process (PPAP). PPAP is a verification process to ensure supplier understanding of our design specifications and requirements. PPAP helps to establish confidence in our suppliers’ ability to consistently meet requirements during production.

 Having a standard for product qualification will:

  • Ensure one voice to the supplier from MiniMed
  • Enable a risk-based qualification of products via a standard checklist which will result in a consistent set of deliverables

Drive qualifications for sub-tier suppliers and establish controls to help reduce the risk of delivering non-compliant products to customers

Supplier Quality Management (SQM)

Supplier Quality Management (SQM) is a service to understand and control product variation in a real-time. To provide the most reliable and robust products to our end users, the doctors, and most importantly the patients that we serve.

 This is accomplished using a system in which data can be uploaded and valuated against the specific product requirements and identify opportunities for process excellence. Additionally, this will provide instant feedback and notify the manufacturer and customer of potential issues to product quality.

 Regulatory bodies have required more robust controls for supply chain and the products manufactured. SQM provides a safe secure system for compliance to these regulations as well as a tool for collaboration between manufacturer and Medtronic.

 MiniMed expects:

  • An attitude of ownership from manufacturers
  • Integration of SQM into product requirements and personnel training
  • Timely communications regarding issues, changes, and resolutions

Go to the Supplier Quality Management portal