by Janet Jacobsen
Routine floor audits and data-gathering protocols uncovered some surprises at MEDRAD—up to 20 percent of all in-process device history record (DHR) packets contained an error. This rate was particularly troubling because MEDRAD employees were double- and even triple-checking the required paperwork for the medical devices manufactured by the company to ensure accuracy prior to submission to the product release coordinator.
The company, located in Pittsburgh, PA, is a global leader in developing, manufacturing, selling, and servicing diagnostic imaging and therapeutic medical devices used to diagnose and treat cardiovascular and other diseases. A 2003 winner of the prestigious Malcolm Baldrige National Quality Award, MEDRAD earned $525 million of revenue in 2007 while employing more than 2,000 people.
-MEDRAD, a medical device manufacturer, devoted tremendous resources—both human and financial—to maintaining the paper trails required in a government-regulated environment.
-The manual recordkeeping processes related to product history records for each medical device assembled by the company were not only time consuming, but also prone to high error rates.
-By following the company’s IMAGES® continuous improvement methodology, a process improvement team focused on reducing errors while supporting production growth and reducing manual effort.
-Using a three-tiered approach that included technology-, process-, and people-related solutions, MEDRAD realized an impressive 26-percent reduction in overall record errors.
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Tools and Concepts Featured in this Case Study
- Continuous improvement
- Cause-and-effect (Ishikawa/Fishbone) diagram — download template (.xls)
- Failure mode and effect analysis (FMEA) — download template (.xls)
- Pareto chart — Download template (.xls)
Operating in a government-regulated environment, MEDRAD places great importance on product and operational quality as well as on specific paper trail requirements such as DHRs. Created for each medical product assembled, DHRs contain records of the manufacture date, assemblers responsible for manufacturing, test results, and more.
DHRs are also known as traveler packages, according to Matt Boyle, plant quality manager. “The traveler package is simply the paper documentation that travels with the unit during assembly. The manufacturing steps are recorded, signed, and dated; this becomes our objective evidence that the unit was built to specification,” explains Boyle, an ASQ Senior member and the chair-elect for the Pittsburgh Section.
In 2004, routine floor audits uncovered that up to 20 percent of all in-process DHR packets contained an error. Additionally, data collected during a subsequent protocol confirmed that processes for assuring DHR quality prior to product release were ineffective and causing unnecessary rework and delays during the product release process. The data captured the attention of company leaders in the compliance and manufacturing areas and led to a continuous improvement project to reduce the error rates.
At MEDRAD, the impact of all continuous improvement projects is assessed against five corporate objectives as follows:
The DHR error reduction project supported all five corporate objectives in varying degrees, with the highest priority devoted to improving quality and productivity. The team was tasked with making significant improvement in the quality of DHRs by reducing error rates prior to product release review from 20 percent to 5 percent while developing processes that wouldn’t negatively affect efficiency or interfere with growth capacity.
The improvement team identified key stakeholders for the project by focusing on areas of the business that would experience the most impact, such as regulatory and corporate compliance, quality, and operations. Representatives from these areas were invited to provide oversight, sponsorship, and input at the corporate, plant, and department levels. Maintaining cross-functional representation on the improvement team was key for all stakeholders, as was the opportunity to approve changes to procedures.
The improvement team, which finished fourth in ASQ’s 2008 Team Excellence Award process, followed MEDRAD’s IMAGES® Lean Six Sigma continuous improvement methodology. The acronym represents the key stages in the company’s quality improvement process:
Identify the problem.
Measure the current state.
Analyze the root causes.
Generate potential solutions.
Experiment and then execute prove solutions.
Sustain improvements over time.
When identifying possible root causes for the high error rates, the team used the following analysis tools:
A cause-and-effect diagram, shown in Figure 1, was useful for developing strategy on moving from a high rate of errors to no errors. This tool helped team members brainstorm about possible root causes associated with the reported defect types.
The improvement team also created a redundancy/gap matrix by asking: What procedural checks are in place upstream to prevent errors for each inspection step in the final quality control inspection procedure? The result of this activity was a table that made redundancies and gaps easy to detect.
From the matrix and the cause and effect diagrams, the team identified the following final root causes:
The team proceeded to validate these root causes on the company’s Stellant line, the highest volume injector product. The protocol was piloted for four months, which allowed the improvement team sufficient time to identify a correlation between the overall defects throughout all product lines and those found on the Stellant line.
The team’s two-year plan, as shown in Figure 2, focused on three areas for improvement:
The expected error reduction for each of the three solution types was analyzed to help prioritize implementation, as shown in Table 1. For example, while the cost of technology-related solutions was high, this category also had a high probability of success—a projected 29-percent error reduction rate.
The three technology solutions were validated by protocols to ensure the documented testing, qualification, verification, and/or validation requirements were met.
Certain types of DHR errors, such as missed checkboxes, incomplete DHR travelers, and missing serial numbers or labels, were best resolved using process improvements. Table 2 illustrates the correlation of error types to potential solutions.
The team’s improvement solutions included launching new device review travelers, creating and placing labels with visual work instructions (VWIs), incorporating the slash mark to cross out non-applicable areas, and improving DHR travelers by:
Once the technology and process solutions were in place, the team turned its attention to errors related to the accountability of the production associates responsible for completing the DHRs. These types of errors involved record-keeping as well as missing signatures, data, and paperwork. The four solutions selected were:
MEDRAD used two methods to motivate production team members to improve their quality performance related to DHRs:
In concert with these methods, MEDRAD also provided timely feedback to production associates through daily performance tracking for each production cell and the overall production team. Secondly, the company developed a process to ensure that supervisors receive notification of errors and review them with the responsible associates on the same day the error occurs.
Within just six months of implementing the people-focused solutions, the error rate fell below 5 percent and the project team achieved its goal, as depicted in Figure 3. Performance improvement continued throughout 2007, and the error rate stood at a mere 2.2 percent for 2008.
As shown in Table 3, the tangible benefits of the improvement project were significant as MEDRAD saved $40,000 while reducing its overall DHR error rate to less than 5 percent.
In addition, the project was also credited with several intangible benefits, including:
While the team learned a great deal about process improvement throughout the project, one of the key lessons focused on documentation, as Boyle explains, “We had to educate people about the importance of documentation quality. The mind-set and focus of our assemblers tended to be on product quality and not on how accurately they completed the documentation.”
As noted earlier, all continuous improvement projects at MEDRAD are assessed against five corporate goals. The impact of this project dovetailed nicely with corporate goals as follows:
To support the implemented solutions, 70 quality system documents were revised, which required training to implement and sustain. While no quality system procedures were revised for the people-related solutions, the results have been sustained through the objective-setting process and by lowering the error rate objective in pursuing continuous improvement.
The company introduced a DHR database, which provides the measurement system necessary to monitor performance. Both trend and Pareto data are reviewed during monthly quality council meetings and quarterly management review sessions. Goals are revised annually based on continuous improvement. In addition to trend and Pareto chart data, statistical process control is used to evaluate the performance of the process and to detect when changes occur.
Janet Jacobsen is a freelance writer specializing in quality and compliance topics. A graduate of Drake University, she resides in Cedar Rapids, IA.
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