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In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). 

However, experts in RCA emphasis that it’s critical to teach pharmaceutical employees the difference between direct and root causes in training on the root cause analysis process, and how to identify which of the two they’ve found. And then, ensure that the root cause and all contributing causes are adequately addressed in the proposed CAPAs.

In some cases, pharmaceutical employees don’t put enough effort into performing an RCA. They stop at the easy or obvious answer — often operator error — and apply a correction to that rather than making an effort (or putting enough effort in) to identify the root cause. This can be due to rushing the process or expecting people to perform RCA without the kind of effective training offered by Tonex.

In other cases, companies halt their RCA process at the direct cause, instead of continuing until they’ve identified the root cause. Worse, many don’t even realize they’re doing it. They think they’ve solved the issue when what they’ve really done is remove an indicator of an underlying issue — leaving the real problem to fester and recur at a later point.

Another important step is to teach employees a technique that will help them drill down through those underlying causes. One of the strongest tools is a 5 Whys analysis. At first inspection, this process doesn’t look very robust, but in reality, the tool is very easy to use and is very effective at identifying the underlying causes that enabled a problem to occur. 

Every team faces roadblocks in its daily work. However, using the 5 Whys will help you find the root cause of any problem and protect the process from recurring mistakes and failures.

One of the key factors for successful implementation of the technique is to take an informed decision. This means that the decision-making process should be based on an insightful understanding of what is actually happening on the work floor.

In other words, the root cause analysis process should include people with practical experience. Logically, they can give you the most valuable information regarding any problem that appears in their area of expertise.

When applying the 5 Whys technique, you want to get to the essence of the problem and then fix it. Actually, the 5 Whys may show you that the source of the problem is quite unexpected.

Want to learn more? Tonex offers Clinical Trails and Pharmaceutical Root Cause Analysis Training, a 2-day workshop style, hands-on training course designed for professionals in clinical trials, biotech and pharmaceutical industries.

Tonex’s Clinical Trials and Pharmaceutical Root Cause Analysis Training workshop ensures professionals involved in conducting investigations learn more about the RCA tools and gain practical knowledge to drill down to the root cause(s) of an event.

For more information, questions, comments, contact us.

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