Do pharmas overuse "Human error"?
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.
Take a hard look at your documentation
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:
- Are your organization's change processes lengthy and cumbersome, so employees are working with out-of-date, obsolete SOPs?
- Do your SOPs and batch records match up well? Are they consistent in terminology and structure?
- Are your SOPs readily accessible? Can employees easily navigate to and understand the information they need?
- Do employees trust the documentation, or have they become accustomed to seeking answers from other sources?
- Are the procedures presented to employees during training cycles different from the ones they follow on the job?
Free white paper
Implementing a corporate content standard can help pharmaceutical and medical device manufacturers reduce cGMP deviations. Find out how in this free paper: