Did Someone Call for a Supplier Quality Engineer?

The window of opportunity for design decisions to reinforce design for quality can be missed by bringing in a Supplier Quality Engineer after the design transfer step in the production process. Marnie Smith, senior director of quality at Network Partners group explains the importance of an SQE and just when one should be brought in.

MD+DI: Let’s talk about why many companies still use a mindset of SQE involvement post Design Transfer. Why do companies fall into that trap and what are the pitfalls of going into that mindset? Who are the biggest offenders in this? Is it larger companies or smaller firms that are the worst offenders?

Marnie: Companies that typically fall into this trap are ones that are sticking too firmly on a ‘checklist’ approach to quality activities or a broken culture of Quality that puts all of the QMS requirements in one bucket, “that’s quality’s problem, not mine” style of thinking. This tends to be with companies newer to the space who may not have had as much experience in understanding the foundation of quality within the medical devices. Within this space, the Quality Management System (QMS) is the foundation for running the business, it is put in place by top leadership, and all functions have accountability to the QMS and product quality. What does this mean for Supplier Quality? With a ‘checklist’ approach, it’s focusing exclusively on the Purchasing Controls aspects of FDA requirements – establish the approved supplier list (ASL), have a process to get suppliers on/off this list, performance metrics…all necessary activities but it does not take into account the more nuanced challenges that exist within the design process that supplier capability and expertise can impact.

That said, large and mature companies can have a similar problem, especially if the SQE role has sole accountability for metrics. If an SQE is only being measured on how their supplier is performing, it drives reactive thinking. They don’t have time to support the new product development process because they are prioritizing the post-design transfer sustaining changes. Most companies fall into this trap because they don’t view Quality as a partner/advocate. Utilizing Quality early in any process is a proactive approach, something companies seldom do because it means potentially spending more upfront without understanding the cost savings benefit of avoiding issues/rework/stop ships/etc.

MD+DI: When is the best time to bring in the SQE? 

Marnie: The best time to bring the SQE into the picture is after User Needs are established and right as Design Inputs (DIs) are being defined. This is a critical point because the supplier can speak to supplier capabilities upfront which can influence how the DI is phrased to set up later for effective V&V. Not only that, there is a cost benefit here where an SQE can speak to technologies that may have lower cost throughout the life of the product. An additional benefit an SQE provides is help with supply chain, supplier relationships, material expectations, and so on. Perspectives like “If we go with XYZ, we wouldn’t be able to ship to China which is on the go- to-market plan. Maybe start with ABC alternative”

MD+DI: Ultimately what is the role of the SQE? With the recent changes in the Supply Chain and issues that have occurred since the pandemic has the role of the SQE changed?

Marnie: The role of the SQE exists within the [boundaries] of Compliance, Design, and Manufacturing. From a compliance standpoint, they are ultimately the gatekeeper for Purchasing Controls, accountable for their suppliers being compliant to applicable procedures, regulations, and standards. This includes metrics tracking, such as supplier scorecards and communicating defects, as well as supplier qualifications, supplier audits, and supplier assessments. However, they also hold a critical dual-purpose function within their role. For the OEM, or the place they work at, they are the voice of the supplier to the internal teams. For the suppliers, they are the voice of the OEM communication of all the requirements and feedback. They have opportunities to advocate or challenge decisions in this dual space. 

With supply chain issues resulting from the pandemic, their roles became immensely more challenging. OEM-established supply chain relationships began to deteriorate with delivery issues and businesses shutting down, and in some cases, going under. In a space where the bulk of relationships are single source and with supplier performance so heavily weighted on metrics, supplier performance, and component shortages certainly impacted the role and caused challenges with product delivery and QMS compliance. If components were being consistently late because of events out of the supplier’s control, it artificially triggers internal QMS processes insinuating supplier problems. If businesses are shutting their doors, what alternate supplier options are there? These situations ultimately led to increased lead times and late delivery of products impacting patients in need. For the Supply Chain Mgmt., they were scrambling to identify more suppliers that may have not met the bar previously with respect to quality and capabilities. For an SQE, it left them scrambling in ensuring that new supply chain options were still meeting quality requirements. It also made SQEs have to apply some risk-based management techniques or face applying cumbersome processes to suppliers that didn’t need it or vice versa, which is the state of many companies today.

MD+DI: Do you have any nightmare scenarios of bringing in an SQE too late that you can discuss?

Marnie: I worked at a company that didn’t have any supplier quality support for the entirety of the company, let alone within the design process. Post-launch of a new product, many issues were seen resulting in a finger-pointing scenario between engineering and the supplier. It was very divisive. I was able to hire an SQE and immediately put them in the awkward position of having to deal with that relationship fallout. That involved a lot of interpersonal conflict resolution and ultimately resulted in a lot of post-launch design remediation because the root of many of the issues landed in drawing specifications being made that were not manufacturable. 

Another situation I had involved a supplier transfer of machined components of product on the market for several years. This program involved many complex parts going to new suppliers my site hadn’t worked with before, but suppliers that had been partners with sister sites within the organization. One of the first things that happened during the drawing reviews was the new supplier pointing out “these dimensions are overly constrained and can’t be made, has your existing supplier ever said anything to you?”. Samples were measured and sure enough, the parts didn’t meet the specification. Because some of those dimensions impacted critical to safety design features of the product, we had to jump into a retrospective analysis evaluation and assess field action decisions. We were fortunate enough to have data to support the existing product remained safe for use, but you can easily see a costly recall would have had to been executed. The true question remains, why didn’t the original supplier bring this point up in development? These types of situations frequently occur.

MD+DI: What are some tools that can help support the SQE?

Marnie: The standard Quality toolkit applies here with using Design for Excellence (DFX) and Deming’s Total Quality Management. DFX is especially instrumental in the product design process, very powerful and effective design decisions can be made early in the design process that will make many stakeholders happy. My particular favorites include DFM (manufacturability), DFQ (Quality), and DFS (sustainability) which certainly has a vested interest by suppliers. TQM provides a framework for continuous improvement activities that result in customer satisfaction. 

However, the most important tool for an effective SQE is effective communication. The supplier/customer relationship can be a sensitive space. The supplier wants the business, and the customer wants things the way they think is right. Ultimately, we all have to remember what’s really important is safe products, and when we remember that it lays the foundation for constructive conversations that lead to improved product quality. Having a relationship built off this foundation, leads to a relationship based on trust that allows for open and constructive conversations.