Root Cause Investigation – Foundation of CAPA

Effective root cause investigation is the key to designing and implementing effective corrective actions restoring data integrity and full regulatory compliance.

Conducting an effective root cause analysis requires a commitment to delve deeply enough into the pattern of facts that comprise an incident that one reaches a point at which what, when, who, and how yield an exhaustive and actionable set of reasons why this happened.

This requires structure and rigor to achieve. There are a number of root cause analysis approaches and tools with which most are familiar. They include the Fishbone analysis, the 5-Whys, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Kepner-Trigoe, and so on. In each case, the way the methodology chosen is applied it is most important. The analysis needs to be conducted to exhaustion, that is, to a point beyond which asking further factual questions can yield no new answers, no additional layers.

Asking someone connected with the problem or failure to conduct the root cause analysis is a flawed strategy no matter what methodology is applied. An independent and dispassionate perspective is required to ensure that the analysis is really pushed to exhaustion.

Finally, it is good to remember that “human error” is never a root cause at the exhaustive level. A root cause investigation that ends at “human error” has not probed deeply enough. From the systemic perspective, human error is an environmental constraint, a given, and a risk factor, not a cause.

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