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


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

BioPharm International
Volume 19, Issue 12


Companies facing these questions from either regulators or their QA groups, or both, should conduct a root-cause analysis of their training programs; they should also consider reviewing the effectiveness of their overall CAPA programs in revealing and correcting root causes of performance problems. The following paragraphs describe how to conduct a root-cause analysis of performance training as part of the CAPA program (Table 1).

The Cause-and-Effect Diagram and the 4-M Checklist

Table 2. Training program elements in the 4 M categories
A cause-and-effect diagram is an effective tool for identifying potential root causes of a performance problem. This tool helps managers methodically analyze the factors of a process and visualize their contributing role to the situation. Grouping these factors into the 4-M categories—man, machine, methods, and materials—provides a handy checklist to ensure that all categories are considered. (A fifth category, measurements–metrics, is also used by some organizations.1 ) The four categories can be translated in the following manner: man refers to people (both trainer and trainees); machine is the tools; methods are the procedures, written instructions, activities, etc.; and materials are the training materials (Table 2). A proper root-cause analysis must evaluate all these groups to uncover the cause of the problem.

A cause-and-effect diagram is also known as a "fishbone diagram" because it resembles a fishbone. Each bone represents one of the 4 Ms, and the head represents the potential root cause. Figure 1 depicts a 4-M fishbone diagram with the matching training elements.


Operators and Trainees

Table 3. Possible courses of action for addressing performance problems
Let's start with the first M, "man," and focus on the operators and trainees. For operators and trainees, it must be determined what is causing the performance discrepancies. Performance discrepancies occur when actual performance does not match expected performance.2 For example, a deviation from written procedure or batch record has occurred. The overarching question to address is whether the discrepancy is a deficiency in the employee's knowledge or skills, or whether other factors or a combination of factors are involved, such as training quality or management reinforcement. Determine if there is a lack of procedural understanding, or a case of poorly worded work instructions with ambiguous steps for decision-making. Consider if the training event involved a new procedure with new concepts for which proficiency might have required more time than originally planned. Check training documentation to see if prerequisite knowledge was required, or if trainee skills were missing. Did on-the-job training (OJT) include supervisor or peer involvement to verify that the new procedure was understood? Perhaps this is truly a one-time mistake that has not occurred before. Determine if the operator is assigned to the correct role. Was the trainee able to perform the procedure in the past but has now forgotten how to do it? Consider how often the operator is expected to perform the task. Explore how often trainees are receiving specific feedback regarding acceptable standards, and how often they are practicing the skills needed to perform.

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