Title Why “Human Error” Should Never Be an Assignable Root Cause Author Devin I. McElroy, M.B.A, Sr. Director of Quality Reviewers Washington Osiro, M.B.A. (cand.), Director of Quality Engineering Sormeh Mahjouri, M.P.H., Regulatory Manager Introduction Are you frustrated by ineffective corrective actions and dealing with the same defects over and over again? The cause of many ineffective corrective actions are the assignment of “causes” that are not actually the root cause. For instance, assigning a root cause of “human error” will never lead to the prevention of repeat defects from
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