Considerations in Laying the Foundation for Quality in Outsourced Manufacturing—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

When a medical device manufacturer outsources manufacturing, they aren’t just outsourcing product assembly; they are outsourcing their reputation. As a result, it is important not only to have an inspection and test strategy capable of catching defects before they escape the factory, but it is also important to eliminate defect opportunities.

Axiom Electronics is an electronics manufacturing services company that serves multiple mission-critical industries including medical, defense, and aerospace. In this Q&A, Andrew Kemper, President of Axiom Electronics, discusses key elements that lay a foundation focused on eliminating both defects and defect opportunities.

Sean Fenske: Can you expand a little on the concept of defect opportunities?

Andrew Kemper: While quality control focuses on catching any defects that slip into even a well-controlled process, quality assurance focuses on eliminating the issues that create the opportunities for defects to occur. That focus involves Design for eXcellence (DFX) principles, as well as common sense practices such as having a 5S factory cleanliness discipline in place or considering the impact that material handling practices may have on accelerated component degradation in harsh environments. We’ve built products that have gone to the Moon and Mars. There are no do-overs in those types of space products, so our internal culture has to be focused on mistake-proofing everything we do.

Fenske: What is the difference between DFX and Design for Manufacturability or Design for Testability?

Kemper: DFX incorporates both DFM and DFT. It also considers Design for Fabrication (DFF), Design for Cost (DFC), Design for Quality (DFQ), and Design for Use Environment (DFE). It helps identify not only design issues that can impact production but also design issues that may impact the product’s ability to function in the field. When a device manufacturer and EMS partner take this type of 360 approach collaboratively, it can reduce design iterations, assembly cost, and defect opportunities. When a project has already completed design and validation phases prior to EMS provider selection, our engineering team can work on mitigation strategies should any DFX issues be identified.

Fenske: How do you ensure a good transfer of information at project start?

Kemper: It is very important to have a formal new product introduction (NPI) process. In our process, we evaluate scope of work, documentation, special requirements, manufacturing processes, and material handling considerations at both the quote phase and at the start of NPI. We also look at traceability requirements and any operator certification requirements. Most EMS providers do something similar. I think the biggest difference is that with our space background, we tend to look more closely at small things peripheral to manufacturing processes that could cause larger issues later. We also identify areas where project requirements aren’t well defined or may be inconsistent across the documentation, and work with the customer to clarify them.

Fenske: What supply chain quality considerations are important?

Kemper: We are currently seeing increases in allocation in some commodities. Anytime parts go on short supply for extended periods, the risk of counterfeits increases. So, having incoming inspection processes designed to identify packaging inconsistencies and stringent validation processes if parts are procured through brokers is very important right now. Allocation also puts older inventories in play, so moisture-sensitive device handling and good inspection and test processes are also important. Older inventories can also have higher infant failure rates, so good test coverage is critical.

Fenske: What role should inspection and test play?

Kemper: Inspection is the canary in the coal mine. It helps you catch process-related issues early and keep your processes in control. The earlier in a process that a defect is caught, the less rework or scrap you have. A test strategy that gives you good test coverage is a check and balance helping prevent defects from escaping the factory. We do inline 3D AOI inspection on our SMT lines and utilize a combination of 2D, 2.5D, and CT imaging to inspect hidden solder joints. For testing, we can use a combination of electrical test, functional test, and environmental stress screening depending on customer requirements.

Fenske: What other elements are important in laying the foundation for quality?

Kemper: I think the biggest issue is culture. Our employees understand that the work they do is often mission critical. Another key element is focusing on the basics. The solder joint is the critical link in every electronic product. If your process is producing superior solder joints, your products will be superior quality. We have team members who have helped write solder joint workmanship standards and regularly participate in industry committees studying assembly processes.

Fenske: How do you ensure your lessons learned transfer to the right people at the customer?

Kemper: Outsourcing manufacturing shouldn’t be a handoff. It is a partnership. Engineering teams need to understand if their design isn’t translating well to production or if there are inconsistencies in their documentation. If the product has been outsourced for a long time, there may be inconsistencies resulting from engineering changes implemented over time. Our team documents every issue and provides that feedback to relevant personnel at our customers. That isn’t a given in EMS. Some companies just fix the issue and never tell the customer the problem existed. When that happens, customer engineering teams lose relevant knowledge that could improve future product iterations. We do our best to keep them in the loop.

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