Is your supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.
“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 keep the results of poor supplier quality from spreading,” according to Holbrook, a senior product manager with 20 years of industry experience in manufacturing and seven years in product development of medical devices.
To anticipate supplier quality issues before problems spread, manufacturers should be mindful of the following five red flags, which should alert you to declining supplier quality.
Warning Sign #1: Failing Parts Per Lot
Part deviation happens, but when a pattern of non-conforming sourced parts or materials begins to emerge, that should raise a red flag. Especially in industries like medical device, it is important to measure supplier defect rate and manage nonconformance effectively.
“Manufacturers should have a robust supplier quality management system (SQMS) to alert a supplier to a nonconformance, conduct root-cause analysis, initiate a supplier corrective action request (SCAR) and follow up on corrective and preventive action (CAPA),” Holbrook wrote.
Warning Sign #2: Slower Responses to Inquiries
If a usually responsive supplier becomes slow to respond or, worse, completely unresponsive, to your communications regarding quality issues, scorecards, ship dates, etc., it may mean the supplier is avoiding you. This is especially worrisome if the supplier isn’t updating you about quality issues when you bring them up.
“Communication between manufacturers and their suppliers should be straightforward, frequent and reciprocal,” according to Holbrook. “Open communication and proactive collaboration facilitates transparency between both partners to minimize complications with specifications, materials and parts needs.”
Warning Sign #3: More Missed Ship Dates
If a typically reliable supplier fails to deliver orders on time, especially over time, this is cause for concern. A supplier’s slow progression of missing shift dates often indicates a failing manufacturing process is affecting quality.
“If a supplier is delivering orders late, it is critical to determine the root cause, especially if the situation is getting worse,” Holbrook wrote. “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.”
Warning Sign #4: Evasiveness During Audits
If a supplier seems to be withholding quality-related information or keeping you from focusing on a particular area during an evaluation (or mini-audit), this may be a deliberate attempt to divert your attention from quality-related documentation or process problems.
During supplier evaluations, it’s important to investigate the area further, “actively listen, be able to read and understand situations, and stay focused on achieving objectives,” according to Terrance. “Done right, a supplier audit enables you to uncover potential problems before they become major problems.”
Warning Sign #5: Wave of Organizational Exits
If a supplier sees a surge in organizational exits of key leadership or personnel in quality, this is a clear warning sign that something is amiss.
“Mass exits may be indicative of serious quality-related problems with the supplier’s goods, services, processes or overall business,” Terrance wrote. “[I]f 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.”