Four Dangerous Myths about Quality that May Cost Lives
Important lessons from a medical devices quality veteran.
Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known and appreciated, and that can cost lives. Conversely, when executives and manufacturing personnel understand the benefits of a QMS, patient outcomes improve, the quality of life is enhanced, and manufacturers prosper.
In the medical devices field, where I’ve practiced for 30 years, I have seen a fair amount of ignorance about the benefits of quality management. Inevitably, I’ve also witnessed the results of inadequate quality management—device recalls, lawsuits and unfortunately, injury, even death.
How is quality misunderstood? Here are four counterproductive myths I’ve encountered over the years that have led to product failures affecting patients:
People oppose regulations – They don’t want to be told what to do or how to do it. A product development manager once told me, “You can make me sign this document, but you can’t make me follow it.”
Quality costs money – “Changing the way we do things will be too expensive.”
Quality wastes time – “Developing metrics to monitor and improve performance and process takes more time.”
Quality work is boring – “My time is valuable. I don’t want to spend it doing paperwork for a bunch of bureaucratic rules.”
Now, let’s look at the truth about each of these myths to uncover the real and significant benefits of quality management.
Across the Board Improvements
Even though many oppose them, regulations and quality procedures in fact provide a very logical, carefully thought out way to consistently perform and improve processes. When they are correctly implemented, complaints and corrective actions decline, and potential harm is greatly reduced.
Furthermore, quality tools such as kaizen events, cost of quality, or failure mode and effects analysis improve processes and enhance the bottom line while improving the quality of care. They help everyone.
Upton Sinclair’s novel “The Jungle,” which highlighted abuses in the meat packing industry, prompted new regulations that improved the quality of meat products along with conditions for workers. In 1906, the passage of the Meat Inspection Act and the Pure Food and Drug Act led the way to increasing consumers’ confidence in the food and drugs they purchased. The reformative measures imposed by these acts, not only benefitted consumers, but the industries themselves grew more efficient, cleaner and safer as a result.
Reduced Costs and Faster Innovation
Rather than increasing costs, quality efforts generate management information for designing improvements and controlling costs. That data helps them see where they can get the biggest bang for their buck.
Near the beginning of my career, I worked for a dialysis/apheresis manufacturer where we implemented and validated a new mixed model flow line for tubing sets. The change to the manufacturing and inspection processes both increased the efficiencies and decreased costs associated with rework, complaints and returns. Since then, I’ve seen repeatedly how quality management reduces waste. Following the principles of quality improvement empowers companies to cut costs and innovate faster.
No one wants to waste time. Quality management done right results in large quantities of time saved in manufacturing processes. It’s much faster to do the job right the first time than to do it over.
For example, a device manufacturer I worked with chose to not have a second operator inspect the sterility barrier and product label after sterilization. As a result, hundreds of devices had to be recalled. It could have been much worse. Some recalls affect 100,000 products or more.
Often, folks think quality management work is tedious and don’t see the big picture, only how it affects them. In practice, quality procedures help manufacturing operators make fewer errors, resulting in fewer defective products and improved profitability.
For the manufacturing operator, following quality management processes and procedures could mean the difference between losing their job due to poor work versus completing the work faster with decreased non-conformances and rework because they did it right the first time.
Over the years, I’ve found quality management to be a very rewarding field. It’s all about helping people to be and produce their best. The industry provides for learning and a front row seat to ideas as they grow into technological advancements. There is a lot to keep an eye on in this industry.
Whenever I encounter misperceptions, like those I listed, or a lack of understanding about quality, I pitch the benefits.
Quality efforts improve production processes, save time, reduce costs and enhance the bottom line. Rather than an unwelcome burden, regulations and carefully considered quality procedures help everyone, most importantly patients.
Sometimes, when I encounter resistance to an improvement, I invoke the mom test. Would you have this device used on or implanted into your mother? When people understand the most important benefits of quality, they get behind it. Quality systems improve patient outcomes, and that saves lives.
What is a Medical Device?
I thought you might find this interesting.
The Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component part or accessory which is 1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, 2) intended to be used for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or is 3) intended to affect the structure or function of the body, in man or other animals, and which does not achieve its intended use through chemical reaction and is not metabolized to achieve its effect.
Medical devices in the U.S. (intended for human use) are regulated by the FDA. The FDA’s focus is to ensure that medical devices are safe and effective.
Why is a QMS so Important?
A QMS is intended for manufacturers to use to implement quality principles to produce safe and effective products, not just for paperwork, but to meet customer requirements.
A QMS includes design, document and product controls as well as process, labeling, packaging, handling, storage, distribution and installation controls, among others.
A medical device QMS specifically requires measurement, analysis and improvement processes to demonstrate product and QMS conformity and to maintain effectiveness of the QMS.
Organizations are directed to identify the processes required for the QMS and their application throughout the organization and:
- Determine sequence and interactions of these processes (process maps)
- Effectively operate and control the processes
- Make resources and information available to operate and monitor the processes
- Monitor, measure and analyze these processes
- Implement actions to achieve planned results and maintain an effective QMS
Management with executive responsibility are directed to provide all resources needed to maintain the quality system and achieve quality objectives.
Thankfully, it all works together to make life better for you and me.