Root Cause & The 5 Why’s

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?

 

root cause 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.

 

Root Problem

 

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.

 

Root Cause Analysis

 

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.

 

5 Why’s

 

The primary concept behind the 5 Whys is simply asking you and/or your team the question “Why?” five times. This technique is ideal for flushing out root issue theories about the deviation. However, it 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 you have found the true root cause. Further, gathering the supporting data should help you validate the process and if your answer is correct.

 

Determining Root Cause

 

Root cause analysis tools can be detrimental to the outcome of an investigation if they are improperly used. It is important to train people on the proper use for a root analysis. The information needed for identifying root causes in 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 in the root cause tree.

 

Corrective Action

 

Once the event and timeline are properly recorded, a number of questions should be asked during root cause problem solving. For example, each investigation must address the following elements to ensure the true root cause and corrective action is identified:

 

  • 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.

 

Root Cause Investigation

 

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

 

About RCA’s Pharmaceutical Services

 

Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

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Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

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The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

 

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About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

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  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

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