Need to correct cGMP deviations? Look beyond “human error”.

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  • Are your organization's change processes lengthy and cumbersome, so employees are working with out-of-date, obsolete SOPs?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?
The answers to these questions may show you that in many cases the root cause of deviations isn't human error. The real problems may lie in your processes for creating, maintaining and distributing the documentation that drives your quality system.

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:

Free white paper: Do You Need a Corporate Content Standard?