Manufacturing support engineers spend much time trying to reduce defects and other operational problems. We are always looking for a quick fix, at what is different since the last time we made good product, at what adjustment within the validated range we can make that will suit the new lot of raw material. The process […]
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A CAPA is a terrible thing to waste
Economist Paul Romer said in 2004 that ‘a crisis is a terrible thing to waste’. Now we are hearing many saying that we should strive to achieve long term benefits from the current COVID-19 crisis. Whatever about that, in regulatory industries we are only too familiar with CAPA’s, Corrective and preventative actions, which are crises […]
There is Always a Better Way
In recent years there has been considerable interest in improving the processes used to make medical devices and other similar materials. New manufacturing systems such as Total Quality, Six Sigma, Lean Thinking and others have been applied with varying degrees of success.This book focuses primarily on applying these approaches and others to improve the processes […]