I'm always suspicious when anyone uses "human error" to explain away problems caused by poor product quality, bad design or incomprehensible instructions. So when I read some recent articles that blamed up to 80% of pharmaceutical cGMP deviations on human error, my antennae went up right away. A number that high seems suspect, but more importantly, attributing such a wide range of problems to human error can't give you much insight into how to correct them.
When an employee makes an error, there's usually a reason. Pharmaceutical manufacturing operations are documentation-intensive, so if human error is causing cGMP deviations, it's probably time for you to take a hard look at your documentation. When you do, here are some key questions to keep in mind:
Implementing a corporate content standard can help pharmaceutical and medical device manufacturers reduce cGMP deviations. Find out how in this free paper.
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