December 18, 2023 | Tim Diggs

Top Two Reasons CAPA Processes Fail

CAPA Processes

CAPA is part of the root cause analysis process. Putting an acronym to it, and trying to separate it from the process is the start of your problem. People try to skip over or speed through the investigation and move directly to the fix. That will not work. You can not fix or prevent something if you do not understand and know what caused the problem.

The top two reasons CAPAs fail are weak root cause analysis and not knowing the difference between strong and weak corrective actions.

1. Weak Root Cause Analysis

CAPA programs that fail use weak root cause analysis methods that rely on brainstorming or the investigator’s knowledge. You can not learn anything new by only asking about what you know. Limiting your investigations to your current knowledge leads to surface-level investigations. Investigators do not dig deep enough into the problem because they do not know what questions to ask. Immediate indicators of surface-level investigations are proposed root causes like “human error,” “situational awareness” or “machine failure.” What corrective action would I write for “human error”? That is too broad.

To understand, correct, and prevent the problem you have to know what to ask, what to find out, and what to investigate. That’s exactly why you need to use the TapRooT® Root Cause Analysis Process to investigate your incidents. The TapRooT® Root Cause Analysis process is the only root cause analysis that provides expert guidance to the investigators throughout the investigation. Having access to the same questions human performance experts would ask about the problem ensures the investigators will not be stuck in a surface-level investigation. Using the TapRooT® Process you will correctly identify the true root causes of an incident based on factual evidence.

2. Weak Corrective Actions

I attended a presentation in 2022 summarizing a study of the effectiveness of root cause analysis recommendations in Hong Kong public hospitals from October 2016 to September 2018. The study reported that out of 760 recommendations identified in the 216 RCA reports, 2% of the recommendations were rated strong and 82% weak. It is obvious from that statistic that the root cause analysis was poor. Those recommendations would probably have been considered strong if they were correcting a problem regardless of the criteria used to measure the strength.

Once you are digging deep enough and are identifying the true root causes of a problem with TapRooT® Root Cause Analysis, the corrective and preventative actions you need to take will be obvious because you know without a doubt what the causes are. It is really easy to recommend strong and effective corrective and preventative actions in the TapRooT® System.

Imagine having a list of every industry-proven fix you will need to address and prevent your problems. That is what the TapRooT® Corrective Action Helper Guide® gives you. I see some try to categorize corrective actions in an attempt to simulate the knowledge and guidance that is already in the Guide. That is because the TapRooT® System is the only system that has and provides this guidance to investigators. TapRooT® Root Cause Analysis does not stop once the root cause analysis is done. The investigation is not complete until the corrective actions are identified.

So, it is simple. If you want your CAPA program to succeed utilize the TapRooT® Investigation Process. You can abandon all of the acronyms and have a simple, consistent method and terminology that any user, regardless of their background or education level can use successfully.

Attending the Better Improvement Program and CAPA track at the 2024 TapRooT® Summit will be your opportunity to put your team on the right track. Take the 2-Day TapRooT® Root Cause Analysis Course on Monday and Tuesday of the week, attend CAPA best practice sessions like the Corrective Action Workshop, Using Cross-Functional Teams, Learning From Success to Improve Future Performance, Managing Your Improvement Backlog, and more.

Operational Excellence, Summit
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