OEMs tackled the topic of supplier quality during a panel discussion at OMTEC 2015. Here are a few highlights from the conversation on supplier approval, development and priorities.
Paul Hewitt, Regional Sales Manager EMEA, Orchid Orthopedic Solutions
Don Grover, Vice President, Acumed
Joe McDermond, Director Supplier Quality Assurance, Zimmer Biomet
Brandon Schwab, Senior Manager of Quality Engineering, NuVasive
Hewitt: In an age of greater demands on supplier quality, what is the main trend in the area of supplier approval?
McDermond: From a supplier approval process, it’s twofold. When I started at Biomet six years ago, the question seemed to be, how do you qualify the entity? What we brought to the party was the part approval process. How are you actually approving the part? How do you use quality tools to assure that you have a good part?
PPAP is an automotive term, the production part approval process; we started down the PPAP route. Instead of having a couple of parts come in and be approved through 100 percent inspection and call it good, PPAP utilizes the QA tools in terms of what’s the process flow, what’s your PFMEA (process failure mode effects analysis), where are you doing failure mode and effects analysis? We look at the risks of those processes. Then, you get into a controlled plan—how are you mitigating those identified risks? Finally, statistical tools help to prove that you have process capability of the identified processes.
Grover: We’ve done that same thing over the last few years— tried to layer our approach. In the past, we did a Class I pilot—we still do them today—in which you bring in 13 parts, 100 percent of every verifiable dimension, and set up your inspection plans on a go-forward basis. Then the supplier audit—that top level—was hit or miss.
Now we use a layered approach, wherein you approve suppliers so that you know what their processes are, specifically their business processes, not just their technical processes. If there is a problem, you know that they’re going to react. If they move a machine, you don’t have to revalidate everything. That is the top layer, auditing their business systems and making sure they’re keeping records. Then,as you’re saying, the PPAP—we call it a Class I pilot—but many of those elements are in that. The special processes are of great importance. When it comes to anodizing, heat treat, welding, things that you’re not going to mechanically inspect for, how do you ensure that your supplier is keeping those processes in control?
Schwab: We’re more in line with an Acumed approach. We don’t use PPAP out of the box. It’s more about planning. What are the critical quality dimensions? What is the frequency with which you need to inspect? How do we expect you to inspect it? Then use the risk management tools to identify what we need to verify, what we need to validate.
Hewitt: How is the overall development work with your key suppliers an integral part of supplier quality?
Grover: For us, the biggest thing is backing into those process validations—very often it’s those special processes. It becomes a little more difficult for us with sub-tier suppliers, because we rely on the contract manufacturer’s quality and business systems to manage that sub-tier supplier. Are they getting validations? If they’re not—and we’ve been in this situation before, if you’re dealing with a mom-and-pop shop and they’re not great with their process validations—what are you doing to manage that? Are you doing destructive testing on one piece out of every lot, to get your heat treat right? It becomes more worrisome for us, at that point.