GMP Training Primer: Root Cause Analysis

There’s a difference between factors contributing to a problem or error and the fundamental reason it occurred. Create a course that prepares staff to dig down to that root cause with the following outline.

Part One – Overview

As with any other technical training course, begin with an explanation of the topic. What is root cause?  How does root cause analysis (RCA) work? Why is it important to do it correctly? What is the difference between RCA and CAPA?

Part Two – The Four-Step Process

1. Identify the Issue and Investigation Team. RCA begins with developing a problem statement. At this point, the problem statement should be a simple, straightforward description of the problem without speculation or hypotheses. The problem statement will make it clear what personnel or departments should participate in the RCA.
2. Gather Data.Discuss potential data sources and emphasize to trainees that all data must be fact-based and documented. Data or evidence can be gathered from people involved in the occurrence, the equipment or items involved, the location of the problem, and pertinent records and SOPs.
3. Investigate Root Cause. With all data collected, the task is now to ask why the problem occurred and keep asking until you’ve identified all the contributing factors and weeded out the cause. Here, you can introduce the various analytical tools commonly used in RCA. These could include:
   • Pareto Analysis/Chart – a statistical technique for identifying the highest contributing factors;
   • Fishbone Diagram – a visual model of probable causes used to guide discussion of the problem; and
   • Cause and Effect Matrix – a ranking of all factors used to narrow the list of all potential causes and focus on the most likely or important.
4. Take Action. The final step trainees should understand is the process of planning specific long- and short-term actions to mitigate the root cause and prevent recurrence. In this step, responsibilities should be assigned and a plan for monitoring progress created.

Part Three – Follow Up

RCA doesn’t end with the action plan. Teach trainees the importance of evaluating the success or failure of the entire RCA effort as a way to drive continuous improvement.

In next week’s issue, we’ll discuss training employees to handle regulatory inspections.

The complete Root Cause Analysis Overview training package, including slides, leader’s script and knowledge assessment, is available as part of the FDAnews Customizable Training Series for drug manufacturers and devicemakers.

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