Root Cause & The 5 Why’s

A: You aren’t alone in your concerns regarding the inability to identify the root cause when performing an investigation. The regulations for the United States and the European Union require investigations to be performed when deviations in the manufacturing process happen.

The ultimate goal of these investigations is to determine why something went wrong, what caused it to go wrong, and how to address the issue and prevent its recurrence. The analysis is simply a systematic problem-solving approach used for determining the cause of a deviation that occurred during processing and identifying solutions to prevent reocurrence.

The following are a few general considerations to keep in mind while considering root problem and conducting investigations:

• One size investigation doesn’t fit all situations. Simple errors require simple documentation while more serious deviations require broader investigations.
• The best tool to have is inquisitiveness. Ask yourself how far this deviation could extend.
• Widen your perspective. Look for ways to relate, not separate, similar issues.
• Human error is rarely a sufficient cause.
• Always verify information or your instincts and never assume you are correct without proper data to support your instincts.
• Applying these general rules throughout the investigation should help you get to the true cause of the deviation.

Once you have recorded the basics of the deviation, you can begin the root cause analysis portion. Many tools can assist you through this process. Choosing the right analysis tool is crucial in assuring the process ensures the true root cause has been identified. Keep in mind there is no one right tool to use for analysis, and the tool you choose does not need to be complex to achieve its purpose.

Some of the available tools include brainstorming (e.g. 5why analysis, the 5whys, 5 y’s analysis), flowcharting, and fishbone diagrams. Using some or all of these tools in combination during an investigation is practical and necessary. Most investigation teams start off with the brainstorming technique.

• Historical evaluation; have we seen this before on this or other products? Have we seen this before on this line? Have we seen this before with these operators?
• An evaluation of the process or methods used by the Operations team
• An evaluation of the materials used during the operation
• An evaluation of the equipment/instruments used during the operation
• An evaluation of the personnel involved
• An evaluation of the laboratory analysis associated with the operation
• A review of the validation information for the operation.

Whatever tool/tools you use to identify the root cause of the problem, they need to be supported by a robust, well-documented investigation. Some of the critical elements needed to be addressed in the root cause investigation include a clear, concise description of the issue that delineates what happened. Additionally, when it happened in the process and an accounting of who was involved or observed the incident is also critical.

In any case, other information to be addressed in the investigation is a record of the immediate action that was taken to contain the situation. The investigation should be broad so that all possible causes of the deviation can be captured and evaluated as the possible root cause.

Root Cause Corrective Action

Finally, investigate all possible causes so they can be properly eliminated and reveal the systemic root cause. Remember that there could be multiple answers to find the root cause. If you keep these investigational elements in mind and thoroughly document the investigation, you should have no trouble identifying the true root cause of a deviation. Further, your team can apply the findings from the root cause tools and implement corrective action needed.

Article Details

Pharmaceutical Technology
Vol. 43, No. 2
Page: 54