As a medical product moves through development to production stage, establishing supply chain controls to ensure reliable suppliers is critical to satisfy regulatory requirements for your device. ISO 13485:2016 has specific language around supplier controls that needs to be addressed in your QMS. It includes the additional requirements of supplier performance evaluation and controls appropriate to the proportionate risk associated with the medical device.
Here are some tips to help you meet regulatory requirements around supplier controls and to de-risk your supply chain.
- Establish clear links between your QMS, your device quality plan where you identify critical parts, and the criteria your supplier is expected to perform to as outlined in a supplier quality agreement. If possible, use your ERP system to manage these links so that the review and improvement process is easy to manage. For example, our ERP system can be set to put suppliers on hold automatically when a supplier is due to have their evaluations or quality agreements updated.
- When evaluating and qualifying your suppliers to provide you with parts for your medical device, don’t stop at evaluating their quality controls and establishing performance metrics. Include capability as a part of your evaluation. Not only does this allow you to establish more specific performance metrics for the type of materials they supply, but is also a great way to create a supplier landscape. This landscape will become invaluable to other development projects and will help you partner with reliable and capable suppliers early in the design process.
- Establish strong partnerships with your suppliers. Involve them early and often in design or transfer process. They can provide invaluable feedback on manufacturability of your design and educate you on materials and processes in their area of expertise. That knowledge can help you identify risk in the fabrication process at your supplier for inclusion in your risk analysis and mitigation plan.
- Design a supplier review process with a cadence that makes sense and is appropriate to the risk mitigation needed. Suppliers of critical parts, or parts critical to the safety of your device users, will require much tighter controls around conformance and performance monitoring. Your review of their supplier performance metrics will be on a shorter cycle and much more in depth than for suppliers who do not supply critical parts. This enables you to not only foster an expectation of continuous improvement with your supplier, but will also help you identify those suppliers who are not performing to the required standard and allow you to act as appropriate to correct that supplier or find another who is more suitable to your application.
Supplier controls in a regulated environment need not be clumsy or burdensome, but they do need to be well thought out, clear and process driven to ensure you are doing enough to de-risk your supply chain.
Kathy Young is the StarFish Medical Purchasing Manager. Kathy takes a proactive approach to engaging suppliers with the development team throughout the design process. This is her first blog for StarFish Medical.