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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.
Moderator:
Paul Hewitt, Regional Sales Manager EMEA, Orchid Orthopedic Solutions
Panelists:
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.
Schwab: Early on, as a smaller player, we worked with smaller suppliers. As we’ve evolved, we’ve tried to exercise more discipline in supplier selection. A lot of the good suppliers have grown with us. Certainly there was a lot of churn. Now we’re getting to the strategic supplier development. That’s been interesting, having that discipline to drive business toward the folks we want to work with, and develop them. Doing that brings wins across the board for everybody.
As an OEM, the more that we work with a supplier, the more clear our expectations become; you get that rapport and chemistry that can help in meeting the quality expectations and lead times, because things become predictable. As we develop strategic relationships and long-term agreements, that helps the contract manufacturers—it’s assurance in business. It allows them to invest in capital equipment or even process development, so that you can make things more efficiently, more economically.
McDermond: I think that you two are further ahead on the supplier development. I have a great passion for it. I’ve been that resource, and I’ve managed the resources in supplier development groups in other industries.
If it’s strategically motivated and a supplier needs help, either through the upfront qualification process to help an audit, or to overcome some deficiencies in quality delivery cost, I go to different sites and ask them to go fix something and come back when it’s done. It’s a tremendous idea, I firmly believe it. But it does bring up the question of how we invest in those resources. The argument is always, well, the suppliers ought to be doing this on their own. At the end of the day, I believe it’s a lot better to try to help out a supplier as opposed to requalify the part with another supplier.
I think it’s a lot easier to work with the supplier and get them to where you both need to be. That’s a partnership. And the OEMs are highly dependent upon the suppliers. It’s not just a hired gun; these are people we truly depend on to help our business.
Hewitt: What do you expect to be the priorities or road blocks for supplier quality development, in coming years?
Grover: It’s cliché, but quality is job one. If you don’t have that, especially for OEMs, you can lose your reputation or have a bad recall. For us, that’s at the forefront of our minds. How do we ensure that the sub-tier suppliers are taking that path, as well?
Schwab: We’re looking for suppliers that want to work with us, that will share our level of enthusiasm for continuous improvement. We’re going to continue to develop new products; we’re also going to continue to develop our internal business processes, and look for suppliers that will want to work with us as we continue to evolve.
McDermond: If I had to pick one word, the word would be proactive. How is a supplier coming to me proactively telling me how they are going to improve quality, how they’re improving delivery and cost, making it a better experience for the end user and the surgeon.
