medical devices

Using DMAIC to Improve Another Improvement Process – CAPA

Medical device companies must comply with FDA requirements to address quality issues through a complex and sometimes inefficient process called CAPA. One such company applied Six Sigma to the CAPA process to significantly reduce rework loops, reduce cycle time and reduce time to resolve rejections.

Apply Cost of Poor Process and Product Quality to Life Sciences Industry

The life sciences industry, which includes the production of pharmaceuticals and medical devices, faces unique challenges that have made it a late adopter of continuous improvement techniques such as Lean Six Sigma (LSS). Most critical are severe government regulation, product approval phases that can span multiple years, and the imperative responsibility to ensure patient safety…