One Step Closer to Mitigating Human Error

One Step Closer to Mitigating Human Error

Ron Kirscht

Lean and Six Sigma tools can be helpful in keeping companies on the continuous improvement journey, but they cannot address everything. In fact, without ongoing initiatives, these practicesoften can plateau, leaving companies to either seek additional means of improving productivity and quality or face the likelihood of regressing.

Medical device manufacturing professionals always are eager to learn operational best practices. And medtech insiders know that processes, standards, improvement events and other efforts are critical to increasing efficiencies and maintaining a more profitable operation. However, the laws of nature can play against you, often in the inevitable form of human error.

A Lean-inspired technique developed for use at Donnelly Custom Manufacturing Company called “error proofing” or “mistake proofing” provides an excellent safeguard against potential harmful results suchmistakes create and can help produce better products with fewer defects—which is anecessity to meet the stringent qualityregulations of medical device manufacturing.

Developing the Process

All medical device manufacturers confront a similar challenge: meeting customer quality in a fast-paced and competitive market. This is particularly challenging for companies that deal in short-run manufacturing and lower volumes. The nature of short-run production is that it generally has fewer opportunities to leverage automation and tends to be people dependant; therefore, it inherently is more susceptible to human error.

The more complex the business the harder it is for pre-packaged continuous improvement tools to be applied. For example, we discovered that existing Six Sigma error proofing practices focused on product design and did not address some of the mindset shifts necessary to effectively implement it in the manufacturing environment where human error typically manifests itself. Instead, several years ago we applied lessons that we learned from Training Within Industry—a Lean technique typically used to prepare supervisors to train employees to solve problems—to create and implement our own error-proofing process.

The reason for this development? We had fallen short of the quality goals set forth by one of our customers on multiple occasions during a single year. After close analysis, the team discovered the bulk of the problems resulted from employee errors. Applying the new error-proofing process to this specific customer’s jobs reduced parts rejection associated with human error by 75 percent year over year and reduced parts per million defect measures by two-thirds. Its not surprising that such a move would improve customer satisfaction as well.

Understanding the Basis

Error proofing is probably a practice you’ve heard of, but it most often pertains to the design phase.

For us, error proofing focuses on the people and especially on the mindsetnecessary to effectively implement error proofing plant-wide. It addresses the human element of the continuous improvement equation, teaching employees how toimplement preventative measures that will decrease the defects caused by errors.

Using scientific research about human behavior, error proofing first teaches employees why mistakes happen and empowers them to examine opportunities to reduce error. Employees work in groups to identify the specific mistake(s) and the root causes of those mistakes, and then brainstorm possible improvements.

Next, these groups evaluate and select the best solution and apply countermeasure(s) to rectify the error. They also maintain the vigilance that is necessary to ensure the countermeasures are effective for the long term.

The example of a railroad crossing can be used to explain error proofing. Mistake-proofing planners determine the best solution at each crossing in order to prevent mistakes caused by the drivers. They are the gatekeepers, in a sense, and the work they do reduces the possibility of drivers causing accidents. In this scenario, mistake-proofing outputs can range from something as basic as posting a warning sign to something as involved as installing a gate or building a bridge.

The complexity of the mistake-proofing steps depends on the risk, cost and effectiveness that each solution potentially canbring. In the end, however, the process develops and prepares employees to become both problem identifiers and solvers.

At its core, mistake proofing encourages employees to do their best and eliminates barriers that otherwise wouldprevent them from taking pride in the work they do. It also builds a sense of trust, encouraging employees to work together as a team and treat others—and their ideas— with respect. The end result is employees who are better positioned for success.

Putting Mistake Proofinginto Action

For the business of medical device manufacturing, mistake proofing can prove vital in reaching higher quality standards and meeting strict U.S. Food and Drug Administration regulations. Fortunately, implementing the process doesn’t have to be difficult.

Consider this real-life general manufacturing example: A company has a complex part on which employees must weld 24 pegs of two different sizes. Before welding, the operator must place the correctly sized peg into each hole, but on occasion places the wrong sized peg into a hole or forgets the peg altogether.

To fix the problem, the manufacturer implements the mistake-proofing process to analyze the cause of the error, as well as its possible solutions.

The result? The team creates a color-coded template that fits directly on top of the part and features holes with numbers, colors and the designations “long” and “short” over each opening that requires a peg. The team also creates a holder for the pegs that provides the right numbers of long and short pegs for each part.

With this mistake proofing initiative, the operator easily can insert the right sized pegs into the corresponding holes on the part in sequence, from one to 24—an effective countermeasure that has resulted in zero defects since implementation.

In medical device manufacturing, similar mistake proofing not only is a possibility, but in many cases, it may be a necessity. Fortunately, the process is suitable for most any low- to mid-volume manufacturer that wants to improve on its Lean initiatives.

Better yet, it can teach you to look at mistakes from human error not as problems, but as opportunities for innovation. That’s good for your employees, customers, products and ultimately, your company’s bottom line.

Ron Kirscht is president of Donnelly Custom Manufacturing Co. and has been instrumental in leading the company’s pursuit to set the standard in short-run molding, including the development of an outstanding manufacturing launch process, shortening lead times, collapsing mold changeovers, adopting Lean concepts, and meeting the demands of just-in-time inventory management.