At the conclusion of performance training events, there is usually some form of assessment of the knowledge gained or a demonstration of skills learned. Then, after the formal attendee documentation is completed, trainees return to work. If a performance problem occurs soon thereafter, an investigation is launched to determine what happened. More often than not, the root cause is documented as "operator error," and the corrective action is retraining. How many times have you heard of this scenario?
What's wrong with using operator error as a root cause? First, it draws regulators' attention to weaknesses in your current training program and the management of the training program. In addition, it identifies flaws in the organization's corrective actions and preventive actions (CAPA) program. Here's why: the label "operator error" sends a blatant message that training wasn't effective and that operations are not in control. That in turn leads to the impression that the CAPA program is weak because the firm conducts inadequate root-cause investigations.Therefore, companies must recognize that identifying operator error as a root cause strongly suggests to external regulators that things are not right, and that the real root cause needs to be more thoroughly analyzed and effectively addressed by the organization to demonstrate that the training and CAPA systems are performing as designed.
HOW REGULATORS REACT TO OPERATOR ERROR
The next potential question suggests a lack of confidence in the organization's ability to perform tasks correctly on the production floor. Subsequent questions follow, including: "How many times does operator error occur?" "Is it with a specific operator?" "Is it with a specific procedure?" and "What is management doing about this?" Be prepared to explain the course of action taken to remedy the situation.
HOW QUALITY ASSURANCE GROUPS REACT TO OPERATOR ERROR