🌴 Understanding Root Cause Analysis

From this blog, you’ll gain insights into:

  1. Defining Key Concepts
  2. Mastering Effective Techniques for Root Cause Analysis

Table of Contents:

  1. RCA: The Definition
  2. Core principles of RCA
  3. Potential Causes of errors
  4. Understanding RCA
  5. Effectiveness of RCA
  6. Methods for Conducting an Effective RCA
  7. Conclusion
  8. References
  9. FAQ

RCA: The Definition

RCA: Root Cause Analysis

Root Cause Analysis, is a technique to identify the underlying reasons behind issues.

Root-cause analysis is intended to reveal key relationships among various variables, and the possible causes provide additional insight into process behavior.

Its purpose is to find the root of a problem (cause), rather than just address the symptoms and to develop effective and long-lasting solutions.

Core Principles for Conducting RCA

  1. Concentrating on the Issue at Hand
  2. Acknowledging the Problem
  3. Collecting Data
  4. Identifying Causes
  5. Carrying out Root Cause Analysis and Identification
  6. Documenting and Implementing Solutions

General Potential Causes

  1. Human Errors
  2. Technical Issues
  3. Organizational Challenges

Human Errors

Human errors occur when individuals overlook details or lack proper focus, often compounded by technical difficulties.

Technical Issues

Technical problems are sometimes connected to human errors and can arise from glitches in the system.

Organizational Challenges

Within a system, the organizational aspect is crucial for ensuring stable processes. From standard operating procedures (SOPs) to overall coordination, if an organization fails to provide necessary support, errors may occur, disrupting operations.

Understanding RCA

Understanding the significance of Root Cause Analysis (RCA) is paramount in problem-solving.

By pinpointing the root cause, effective resolution and prevention of recurrence become possible, akin to the vital role of a root in sustaining a tree. Failure to identify the origin of an issue can lead to substantial damage. Conducting RCA is imperative to halt the perpetuation of problems.

The application of Root Cause Analysis extends its relevance from individuals to organizations. Its absence poses the risk of recurring issues and repetitive mistakes.

Therefore, embracing RCA becomes a pivotal step for continual improvement and positive outcomes, fostering a culture of learning and prevention of errors for both individuals and organizations alike.

πŸ“’ Recommendation: If you are interested in learning something specific about conducting RCA in pharmacovigilance, click here to find out how you should conduct RCA within pharmacovigilance.

“In the pursuit of excellence, Root Cause Analysis is the compass that guides us to the source, empowering us to transform challenges into opportunities for growth.”

Effectiveness of RCA

Conducting a RCA involves analyzing a problem by exploring the layers of causation, starting from the final result and working towards the underlying source.

This funnel method allows for a thorough understanding of the problem and helps identify the root cause more effectively.

Rather than blindly guessing or assuming, RCA employs a step-by-step methodology that helps in addressing the issue at its core.

This approach is highly effective and ensures that the root cause is properly identified.

πŸ“’ Recommendation: I recommend checking out our existing blog post where we explain in detail the CAPA process in businesses, which is an integral part of RCA (Root Cause Analysis) and also discussing about what are CAPA cases in pharmacoviglance as workflow.

Methods for Conducting an Effective RCA

There are several commonly used techniques for identifying the underlying cause of a problem, three of which are particularly popular:

  1. 5 Whys method
  2. Fish bone Diagram
  3. Fault tree analysis

Some other unfamiliar type of analysis are:

  1. Brainstorming Technique
  2. Affinity Diagrams
  3. Pareto Diagram

Here we go, This blog will explain how you can effectively implement these methods in your day-to-day life and professional activities as my preferred, simple and straightforward approach.

What is 5 Whys method?

History

This technique was pioneered by Sakichi Toyoda, the Japanese industrialist, inventor, and founder of Toyota Industries, who introduced the 5 Whys method in the 1930s.

Out of the three methods mentioned above, the 5 Whys is my preferred choice, finding it both favorite and user-friendly, especially within our pharmacovigilance system.

At its core, the 5 Whys method involves iteratively asking “why,” beginning from the final outcome of a problem and progressing until the fundamental cause is uncovered. Each successive “why” question guides the inquiry systematically toward identifying the root cause.

When to use this method
  1. Troubleshooting
  2. Need quality improvement
  3. To find a cause from simple to medium problems
Implementation of technique

The 5 Whys techniques traditionally used to counter measures rather than solutions to prevent the cause. It is effective method in using in service sectors.

By asking yourself these questions in a thoughtful and deliberate manner, you can effectively identify the root causes of a problem.

For Example:

  1. The problem / Struck with action item/ Read the action item and fully understand: Assemble/Collect the problem
  2. Why this action item for me?
  3. Why was it happened? Define the problem
  4. Why is that happened?
  5. And why was it so happened?
  6. Finally, Why is that happened and how may it avoided?
πŸ’¬ Suggestions: Explore into the intricacies of Root Cause Analysis, and explore our insights on minimizing errors in narratives and employing simple hacks to enhance the quality of pharmacovigilance case processing.

Fish bone Diagram

The analysis of the Fishbone diagram alternatively known as the Ishikawa Diagram, herringbone diagrams, or cause-and-effect diagrams.

This diagram is frequently employed to pinpoint the causes of quality defects in products. It is also referred to as a causal diagram and was developed by Kaoru Ishikawa for this purpose.

The fishbone diagram earns its name due to its resemblance to a fish skeleton.

The diagram commonly employs the following categories:

The 5 Ms (used primarily in manufacturing sectors):

Originating with lean manufacturing and the Toyota Production System, the 5 Ms is one of the most common frameworks for root-cause analysis:

  • Manpower / Mindpower (physical or knowledge work, includes: kaizens, suggestions)
  • Machine (equipment, technology)
  • Material (includes raw material, consumables, and information)
  • Method (process)
  • Measurement / medium (inspection, environment)

These expanded by some to include an additional three, and referred to as the 8 Ms:

  • Mission / mother nature (purpose, environment)
  • Management / money power (leadership)
  • Maintenance
The 8 Ps (used in product marketing):

This common model for identifying crucial attributes for planning in product marketing and also used in root-cause analysis as categories for the Ishikawa diagram:

  • Product (or service)
  • Price
  • Place
  • Promotion
  • People (personnel)
  • Process
  • Physical evidence (proof)
  • Performance
The 4 or 5 Ss (used in service industries):

An alternative used for service industries, uses four categories of possible cause:

  • Surroundings
  • Suppliers
  • Systems
  • Skill
  • Safety

Fault tree analysis

Fault tree analysis (FTA) is a form of failure analysis that investigates an undesirable state within a system. Primarily applied in safety engineering and reliability engineering, this method aims to comprehend system failures and pinpoint optimal strategies for risk mitigation.

The utilization of FTA extends across various high-risk sectors, including aerospace, nuclear power, chemical and pharmaceutical processes, petrochemicals, and other industries with elevated hazards.

Applications of Fault Tree Analysis
  1. Uncovering the causal logic behind events
  2. Illustrating instances of non-compliance
  3. Prioritizing events based on risk
  4. Supervising and enforcing safety protocols
  5. Streamlining resource utilization
  6. Contributing to the design of systems

Conclusion

If you’re regularly finding an action item for your daily workflow, it’s essential to know how to uncover and document the root cause analysis (RCA).

By doing so, you can enhance your case-processing skills, acquire new knowledge, and teach others.

Remember, no one is perfect, and mistakes are an opportunity for growth and development. Therefore, don’t stress about making errors, as they can aid in your learning journey.

Instead, focus on identifying the root cause and taking measures to avoid repeating the same mistake in the future.

Each time you uncover the root cause of an issue, you’re building a strong foundation for your journey. Commence your practice today and explore the methods that resonate most with you in your respective field.

“Share your preferred method for conducting Root Cause Analysis (RCA) by commenting below.”

References:

  1. FTA Method
  2. Mind tools
  3. Buffer blogs
  4. Fishbone wikipedai refernce
  5. Asq.com

FAQ:

What is Root Cause Analysis?

Root Cause Analysis, is a technique to identify the underlying reasons behind issues. Root-cause analysis is intended to reveal key relationships among various variables, and the possible causes provide additional insight into process behavior.

What are the popular methods to implement RCA?

Three globally popular methods for defining RCA are widely recognized:

1. 5 Whys Method
2. Fishbone Diagram or Ishikawa Diagram
3. Fault Tree Analysis

What are the types of Fishbone diagram?

1. The 5 Ms (used in manufacturing)
2. The 8 Ps (used in product marketing)
3. The 4 or 5 Ss (used in service industries)

What is 5 Whys Method?

At its core, the 5 Whys method involves iteratively asking “why,” beginning from the final outcome of a problem and progressing until the fundamental cause is uncovered. Each successive “why” question guides the inquiry systematically toward identifying the root cause.

What is Fault Tree Analysis?

Fault tree analysis (FTA) is a form of failure analysis that investigates an undesirable state within a system. Primarily applied in safety engineering and reliability engineering, this method aims to comprehend system failures and pinpoint optimal strategies for risk mitigation.

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.



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Meet Bala, the founder of Drugvigil, a service provider specializing in pharmacovigilance. He’s not only an expert in this field, but also a passionate entrepreneur who enjoys creating new opportunities and helping others grow. Despite starting from scratch, he’s determined to develop his company from the ground up. If you’re interested in his work, be sure to show your support and share his message with others.




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Comments

One response to “🌴 Understanding Root Cause Analysis”

  1. […] πŸŽ‡ Recommendations: I highly recommend reading some of our blogs that extensively discuss quality in pharmacovigilance. Firstly, I suggest “Achieving High-Quality output Best Practices in Pharmacovigilance.” Secondly, I recommend “Minimizing Errors in MedDRA Coding” and “Handling Root Cause Analysis to Identify the Cause of Errors.” […]

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