Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Q: I am a quality professional in charge of investigations. Sometimes our company has trouble coming up with the root cause for some of our investigations. Can you provide some advice on how to effectively determine root causes for our investigations?
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 occur in the manufacturing process. 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. Root-cause 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 recurrence.
The following are a few general considerations to keep in mind while 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 root 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 root 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 in this process. Choosing the right root-cause analysis tool is crucial in assuring the process is effective and ensuring the true root cause has been identified. Keep in mind there is no one right tool to use for root cause analysis, and the tool you choose does not need to be complex to achieve its purpose. Some of the available tools include brainstorming, the 5 Whys, 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. This technique is ideal for flushing out theories about the deviation but may not be ideal for compiling the data needed to prove the correct root cause has been identified. Using the 5 Whys or the fishbone diagram in conjunction with brainstorming adds assurance that you have found the true root cause and have gathered the supporting data. Root-cause analysis tools can be detrimental to the outcome of an investigation if they are improperly used, so it is important to train people in their proper use.
The information needed to determine the root cause for any investigation should be appropriately documented. The first piece of information to be recorded should be a thorough and precise description of the event. A timeline that discusses the process up to the time the deviation occurred should be established. Once the event and timeline are properly recorded, a number of questions should be asked and information collected to ferret out the root cause. To make sure the true root cause is identified, each investigation must address the following elements:
- 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/methods used during the operation
- 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 an issue, they need to be supported by a robust, well-documented investigation. Some of the critical elements needed to be addressed in the investigation to support the root cause include a clear, concise description of the issue that delineates what happened, when it happened in the process, and an accounting of who was involved or observed the incident. Other information that should be addressed in the investigation is a record of the immediate action that was taken to minimize or 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. Avoid jumping to conclusions and investigate all possible causes so they can be properly eliminated, thus exposing the true root cause. Also, remember that there could be more than one possible root cause to a deviation. If you keep these investigational elements in mind, properly apply your root cause tools, and thoroughly document the investigation, you should have no trouble identifying the true root cause of a deviation and defending it during an inspection.
Vol. 43, No. 2
When referring to this article, please cite it as S. Schniepp, “Effective Root Cause Determination,” Pharmaceutical Technology 43 (2) 2019.