Quality Control: Operator Error: Is It Really the Root Cause of Performance Problems? - - BioPharm International

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Quality Control: Operator Error: Is It Really the Root Cause of Performance Problems?


BioPharm International
Volume 19, Issue 12



This article explores unintended consequences of automatically using operator error as the root cause of performance deviations. In addition, the article describes how to conduct a root-cause analysis of training events using a cause-and-effect diagram. The diagram is slightly modified to encompass the "4-M" checklist—man, machine, methods, and materials—while integrating questions and suggestions focused on training system elements.

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


Table 1. Elements of a typical corrective action–preventive action (CAPA) program
When regulators are onsite conducting an inspection or any type of visit that leads to a review of the training or CAPA program, potential follow-up questions are always asked regarding operator errors. The first and obvious question is: "Why wasn't the training effective?" This question can lead to scrutiny of the effectiveness of the training system and an exploration into the types of knowledge checks or learning assessments that are conducted. Be prepared to produce the approved training procedures.

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


Quick Recap
An industry trend is slowly emerging: Not only is operator error signaling an alarm for external investigators, but internal quality assurance (QA) groups, as well, are starting to reject operator error as the root cause of an investigation, especially if it is a repeat issue leading to the uncomfortable questions listed above.


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