Medical Device Manufacturer’s Continuous Improvement Approach Reduces Errors in Records

Quality In Manufacturing

Medical Device Manufacturer’s Continuous Improvement Approach Reduces Errors in Records

Situation Analysis

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 record-keeping 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.

In 2004, routine floor audits uncovered that up to 20 percent of all in-process device history record (DHR) packets contained an error. 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.

Quality Solutions

By following the company’s IMAGES® Lean Six Sigma continuous improvement methodology, a process improvement team focused on reducing errors while supporting production growth and reducing manual effort. 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 proven solutions.
Sustain improvements over time.

When identifying possible root causes for the high error rates, the team used analysis tools like cause and effect diagramming, brainstorming with cross-functional teams, failure mode and effects analysis (FMEA), and Pareto analysis. The team developed a two-year plan for reducing errors, focusing on three areas for improvement:

  • Technology: to eliminate human error.
  • Process: to standardize and simplify DHR travelers.
  • People: to implement systems to enable, measure, and reward performance.


MEDRAD realized an impressive 26-percent reduction in overall record errors. Within just six months of implementing the people-focused solutions, the error rate fell below 5 percent and the project team achieved its goal. Performance improvement continued throughout 2007, and the error rate stood at a mere 2.2 percent for 2008.


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 May 2008, the improvement team presented its project during the ASQ World Conference on Quality and Improvement, finishing fourth in the Team Excellence Award process.

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