03/02/2017
Something to ponder when correcting problems within a quality system: "What drove the human behavior causing the problem? People generally don't just make mistakes because they wanted to." I credit a colleague, Frank Clay for this statement. It's an exact quote from him during his involvement with a failure in a quality system at a large medical device company.
This points to a multitude of considerations in both root cause analysis and the chosen corrective action(s):
1-Did the process have an inherent aspect leaving human interaction in a vulnerable situation?
2-Is the procedure written correctly to match the process?
3-Is the procedure technically correct but use language that can be misinterpreted?
4-Is "read and understand" a sufficient method of training, or should some form of hands on interactive training necessary? (Can "read and understand" be used in conjunction with a test, including specific questions about the problematic language in a procedure?)
5-Are there cultural factors or barriers causing people to behave contrary to the requirements or needs of the system?
Can anyone else think of other considerations and does anyone have additional comments about this concept in approaching the investigation of nonconformances?
This also begs for use of the study of human factors.
