Investigating the Human Error Causes of Drug and Device Manufacturing Problems
For the drug and medical device manufacturing industries, the US Code of Federal Regulations 211.22, Good Manufacturing Practices, states that if manufacturing errors occur, quality control should make sure that the errors “… are fully investigated.”
From past FDA actions it is clear that stopping the investigation at a “human error” cause is NOT fully investigating the error.
Here are three reasons people fail when they are investigating human error issues and when they develop fixes:
- They did not use a systematic process. 5-Whys is not a systematic process.
- The system they used did not guide them to the real, fixable causes of human errors (most quality professionals are not trained in human factors),
- The system did not suggest ways to fix human errors once the causes had been identified (the FDA expects effective corrective actions).
What tool provides a systematic process with guidance to find and fix the causes of human error? The TapRooT® System!
If you would like to read more about how TapRooT® can help you find the root causes of human error, see:
To learn about how to use TapRooT® to improve your investigations of human error, We suggest attending the 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Training. See the list of public course held around the world at:
With your hard work and effort and a system that will find and fix the root causes of human error you can succeed in fixing human error issues and in meeting the FDA’s expectations.