Quality Assurance Professional
Centurion Medical Products
Michelle has been with Centurion Medical Products since 2013. Centurion’s specialty is procedural trays, catheters and catheter securement. Michelle is part of the quality team. Michelle’s responsibilities span team sterilization, aging studies, validation studies, ethylene oxide sterilization, recalls, device specification approval, internal audits, vendor audits and supplier partnerships.
Michelle will be one of the distinguished speakers at the 4th Semi-Annual Medical Device Supplier Quality: Efficiency and Collaboration Conference.
Why is the 4th Semi-Annual Medical Device Supplier Quality Conference important for quality executives?
It is an opportunity for quality executives to share new ideas and to hear new and different ideas on how to approach different challenges in the industry.
In what ways have you made collaboration with suppliers a reality?
Communication is essential. We make a collaborative team effort between purchasing, quality and the supplier’s team to keep the lines of communication flowing. Our team holds conference calls to make sure that we are all on the same page. Then, we have conference calls with our suppliers to make sure that we are on the same page with our suppliers. If necessary, we visit our suppliers for collaboration and our suppliers visit us. During these visits, our suppliers are able to see how their products arrive and are processed once we receive them. When we visit our suppliers, we are able to see the state of the product before it gets to us. Seeing the supplier’s process (including quality checks prior to shipment to us) helps us understand the makeup of the product better and it helps us understand how to communicate any challenges that we see to our supplier.
What internal departments do you feel are important to be included for holistic/cross-functional supplier quality?
The internal departments that are important are shipping and receiving or logistics, quality, operations or warehouse, maintenance, and invoicing.
- Shipping and receiving (or logistics) is the first department that will see and touch the product when it comes in the door.
- This part of the team needs to know what to expect in terms of the visual presentation of the product and the quantities expected.
- This part of the team also needs to know who to contact if there are issues when the product arrives.
- Quality is the department that will perform the quality checks, constantly review the process or processes, and communicate issues to the customer.
- This part of the team needs to know what to expect at each part of the process from the time the product is produced or enters the building until production is complete or until the product is packaged and leaves the building.
- It is also helpful when troubleshooting for quality to understand the transit of the product incoming (container, plane, train, truck, etc.) and outgoing (container, plane, train, truck, etc.). Knowing this type of information helps quality troubleshoot potential issues with physical damage, temperature damage, and packaging challenges highlighted by the transit route.
- Warehouse (or operations) is the department that is responsible for the movement of the product through the facility.
- It is important for this part of the team to understand challenges with packaging, temperature, and potential product damage along with the financial implications.
- Maintenance is the department that will make sure that all equipment runs properly and optimally with minimal interruptions to processing.
- Maintenance needs to be aware of any product issues that will challenge equipment or damage equipment so that the necessary adjustments can be made or so that new equipment can be purchased for the success of the project.
- Invoicing is the part of the team that will create the invoice for services rendered.
- It is important for individuals that are invoicing to have a PO number (depending on the customer) and to have a copy of that PO to make sure that the PO and the invoice match.
- If changes need to be made to the invoice that differ from the PO or the agreed upon price for services, individuals that are invoicing need to know who to contact at the customer’s location to determine if a new PO needs to be generated or to get authorization to make the change to ensure that the invoice will be paid.
- Individuals that are invoicing need to be made aware of any challenges or changes (like additional testing, damage to the product, additional processing, etc.) during production or processing that need to be addressed in the invoice.
- Most importantly, the different teams need to understand how their functions overlap and influence the experience for the customer.
- Team collaboration from beginning to end creates an optimal experience for the customer.
What are some of the benefits you’ve experienced with involving suppliers in early product development stages?
Some of the benefits are customer satisfaction and fewer backorder issues.
Does your organization have a PPAP in place? If so, what are some of the challenges and opportunities with a PPAP?
No, we handle this more through design change controls and risk assessment analysis.
What is one thing you hope to learn or discuss with your peers at the Supplier Quality Conference?
I hope to learn or discuss different views on how to improve various processes.