Every medical device company has a quality system, but does yours provide consistent prevention of problems? Does it encompass your suppliers adequately? If you are honest, most companies I’ve encountered would have to say no to both of those questions. This clearly opens you up to regulatory action – and also to damage to your profitability.Clearly, quality is critical and you must treat it as priority. This may not, however, mean adding more checks and balances or additional process time. In fact, quality processes will be faster and more streamlined if they are done right.
Recent research I led analyzing the responses of Medical Device companies to a study by MESA International shows that over half of companies (54%) have shown less than 1% improvement in the number of non-compliance events they suffer every year. Most of those (37% of the total) have not improved or gotten worse, which must make audits a painful process.
The FDA and other regulators have little patience for that. Auditors expect medical device makers to proactively monitor their quality systems. Are you analyzing and trending nonconformances, complaints, and other sources of quality data all the time, every day? This is challenging with paper, or with spreadsheets, or even old information systems.
Adding to the challenge, regulators have clearly stated that supplier quality is the responsibility of the device maker. So again, I’ll ask: have you seen improvements in your suppliers’ quality? In our research, only 35% had seen at least 3% improvement in suppliers’ product quality at incoming inspection. Even fewer saw improvements in suppliers’ test results or yield. This compares to over half who made that level of improvement in their internal quality as measured by right first time.
A plantwide information system such as manufacturing execution systems (MES) or manufacturing operations management (MOM) can truly act as the foundation for quality. It can provide a basis for prevention, a means to report, as well as the repository for data you can trend and analyze. Operational Intelligence (OI) is the system by which that analysis and trending can take place while production is happening.
Those using plant floor MES/MOM systems were nearly twice as likely as others to have improved their suppliers’ quality at incoming inspection. More than two-thirds of companies using both MES and OI were able to reduce cost of quality as a percentage of revenue by 10% or more.
Since quality is king, why not provide it the lush throne of MES/MOM and OI on which to reign? The regulators and shareholders will all revere the majesty of good quality at a low cost.
Redefining Performance Goals to Unlock Business Improvements - A New Focus for Medical Device Manufacturers