Medical device manufacturers must ensure their suppliers are consistently delivering high-quality parts and materials. Here are five signs that a supplier's quality system or processes may be slipping.

Terrance Holbrook

As medtech OEMs' supply chains grow longer and more complex and regulatory bodies such as the FDA place more focus on upstream activities, manufacturers must know whether their suppliers are reliably producing high-quality parts and materials. But if a manufacturer doesn't know what signs to look for, it will struggle to know if a supplier's quality system is failing, let alone be able to keep the results of poor supplier quality from spreading.

To anticipate supplier quality issues before problems arise, medical device manufacturers should watch for the following five warning signs that a supplier's quality may be waning.

Rising Number of Failing Parts Per Lot

Has a supplier with a long history of compliant shipments begun producing parts or materials that don't conform to your specifications? An increase in nonconformance incidence should raise a red flag.

While it's important to understand that part deviation happens, how a manufacturer deals with supplier shipments of nonconforming component parts or materials is critical to product quality and safety. Especially in the medical device industry, companies must measure suppliers' defect rate and manage nonconformance effectively. Is the problem recurring? What is its root cause? Is it serious enough to require corrective action? Failure to identify, evaluate, and correct such quality issues can increase costs, prolong product delays, and threaten consumer safety.

Medical device manufacturers should have in place a robust supplier quality management system (SQMS) to be able to alert a supplier of a nonconformance, conduct root-cause analysis, initiate a supplier corrective action request (SCAR), and follow up on corrective and preventive action (CAPA). To minimize both the incidence and impact of nonconformance, it's important to communicate and collaborate closely with your suppliers throughout both the process and the partnership. Involving the supplier directly in analysis and being involved in the solution with the supplier will often strengthen the supply chain for both parties.

Delayed Responses to Inquiries

Has a supplier that's typically responsive become unresponsive or slow to respond about quality issues, scorecards, ship dates, etc.? This breakdown in communication may mean the supplier is avoiding you.

When you can't reach your supplier or the supplier fails to follow up after numerous attempts on your part to reach them, it is cause for concern. It is especially worrisome if the supplier isn't keeping you informed about quality problems or clarifying quality-related issues when you bring them up. If there are quality issues in deliveries of component parts or materials, how will the supplier's delayed responses affect your product, business, and customers? A delayed response could result in significant costs in a variety of situations.

Communication between manufacturers and their suppliers should be straightforward, frequent, and reciprocal. Open communication and proactive collaboration facilitates transparency between both partners to minimize complications with specifications, materials, and parts needs. Ultimately, establishing and maintaining clear, ongoing communication with suppliers enables visibility into the source of parts or materials and ensures higher quality for medical device companies.

Progression of Missing Ship Dates

Has a supplier that's usually on time delivering orders been slowly shifting its ship dates? Are you scaling up to meet demand and the supplier's dates start to slip with higher demand? A progression of missing ship dates often indicates a failing manufacturing process is affecting the supplier's quality.

If a supplier is delivering orders late, it is critical to determine the root cause, especially if the situation is getting worse. Why is the supplier failing to deliver on time? Is it due to manufacturing processes or something else? Delivery delays and deteriorating quality tend to be symptoms, not the root cause. If you want to continue using the supplier regularly, you must understand what went wrong and work with the supplier to ensure a solution is put in place.

Setting clear requirements and expectations up front with the supplier is important, but ongoing preventive action is also necessary to reduce quality-related risks and avoid shipments delays. To that end, manufacturers should track and measure suppliers' quality performance; conduct routine supplier evaluations to identify issues that may affect quality; and, ultimately, work together with suppliers to resolve quality issues before they can cause delays.

Aggressive Leading During Audits

Has it ever felt like a supplier is aggressively leading you down certain paths during a supplier evaluations or audit? This may be an attempt to divert your attention from documentation or process problems.

In an effort to conceal certain quality-related problems, a supplier may try to distract you from focusing on a specific area during an evaluation or audit. Does it seem like the supplier is trying hard to direct you away from a particular area? Is the supplier "forgetting" to provide certain documents or records? Evasive withholding of quality-related information should alert you that something may be amiss and lead you to further investigate the area.

Manufacturers should view their suppliers both as partners and as extensions of their enterprise. This entails enforcing quality standards and conducting audits just as rigorously in the supply chain as in their own organization. During supplier audits, auditors must actively listen, be able to read and understand situations, and stay focused on achieving objectives. Done right, a supplier audit enables you to uncover potential problems before they become major problems.

Management Defections/Organizational Exits

Have you noticed a sudden wave of a supplier's key leadership, or personnel in quality or manufacturing departments, leaving the organization? An influx in organizational exits often signifies serious problems.

When things are heading downhill in a major way for an organization, executives and members of the management team may jump ship. Such departures tend to happen during times of great instability or crisis situations, such as a major corporate scandal. Are the supplier's quality or regulatory people exiting because of ongoing trouble with supply? Are they anticipating costly product recalls due to defective parts or unsafe materials they provide? Mass exits may be indicative of serious quality-related problems with the supplier's goods, services, processes, or overall business.

Personnel turnover can be a challenge at any level of an organization for any number of reasons, including natural transitioning. However, if you notice your supplier has a sudden revolving door of leadership or uncharacteristically high turnover among quality or compliance staff, it may be time to start prioritizing back-up partners and qualifying new vendors.

Terrance Holbrook is a senior product manager at MasterControl, where he is responsible for product design and development and market research for software features and functionality. He has 20 years of industry experience in manufacturing fields and seven years in product development of medical devices. A certified Six Sigma Black Belt and ISO 9001:2008 lead auditor, Holbrook is also certified in lean manufacturing and total quality management.

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