Enquire Now
Maree Stuart
Written by Maree Stuart
Maree Stuart is a Analytical Chemist, a Quality expert and a person who thrives on solving challenging conundrums. She has qualifications and over 30 years of experience in science, quality, and management of labs. She helps lab people with gaining and maintaining accreditation, with her no nonsense, practical and innovative approach. And did you know she is also a lawyer?

Root Cause Analysis: Unlocking Problem-Solving Success

When faced with a complex problem, do you find yourself feeling frustrated or stuck? What about recurring issues that never seem to resolve? Or those dreaded negative findings in an external audit, such as a NATA report? These challenges can feel overwhelming, but a powerful tool is at your disposal: root cause analysis.

What Is Root Cause Analysis?

Root cause analysis (RCA) is the systematic process of identifying the underlying reasons behind a problem. While it might be tempting to implement a quick fix and move on, these surface-level solutions often fail to address the true causes, leaving the problem to resurface later. RCA delves deeper, ensuring that your solutions are both effective and lasting.

Why Invest in Root Cause Analysis?

The benefits of a robust RCA are significant:

  • Long-Term Solutions: By addressing root causes rather than symptoms, RCA prevents problems from recurring, saving time and resources.
  • Improved Efficiency: Identifying inefficiencies and bottlenecks often leads to smoother processes and better outcomes.
  • Enhanced Decision-Making: RCA encourages data-driven insights, fostering smarter and more informed decisions.
  • Stronger Compliance: For industries governed by standards such as ISO/IEC 17025, RCA supports compliance by uncovering gaps and ensuring adherence to requirements.

How to Conduct Root Cause Analysis

Several methods can guide your RCA efforts, including the 5 Whys and Cause-and-Effect Diagrams. Let’s explore these:

The 5 Whys Technique

This method is simple yet effective. It involves asking “Why?” repeatedly—typically five times—to drill down to the root of a problem. For example:

  1. Why did the lab QC fail? The equipment was not performing correctly.
  2. Why was the equipment malfunctioning? It did not meet method performance requirements.
  3. Why was this not identified earlier? The calibration certificate was not reviewed upon return.
  4. Why was the certificate overlooked? There was no process for verifying calibration records.
  5. Why was there no process? The team was unaware of the importance of this step.

The goal is to uncover actionable insights, not assign blame. This collaborative approach fosters openness and constructive dialogue, paving the way for meaningful improvements.

Cause-and-Effect Diagrams

Also known as fishbone diagrams, these visually map out potential causes of a problem. Categories such as personnel, processes, materials, and equipment are explored to identify contributing factors. This method provides a comprehensive view, making it easier to pinpoint root causes.

 

Example of Effective Root Cause Analysis

Imagine a laboratory QC failure. While initially appearing minor, an RCA reveals deeper issues:

  • The equipment used failed to meet performance requirements.
  • This went unnoticed because the calibration certificate was filed without review.

 

ISO/IEC 17025 highlights the importance of investigating such failures (refer to clauses 6.4.9 and 7.10.1(c)). Without RCA, significant time and resources could be wasted addressing downstream effects. By contrast, a thorough RCA prevents recurrence, ensures compliance, and protects operational integrity.

Maximizing the Value of RCA

For an RCA to be successful:

  • Involve a Team: Diverse perspectives from a variety of people involved in the problem enrich the analysis, often uncovering insights that might be overlooked by a single person.
  • Ask the Right Questions: Focus on why the problem occurred and how it can be prevented, rather than assigning blame.
  • Document Findings: Create a clear record of the process, findings, and action plans to ensure accountability and follow-through.

By embracing RCA, you gain a powerful tool for tackling even the most persistent problems. This approach not only addresses immediate concerns but also creates a foundation for sustained success and continuous improvement.

 

We can help!

We’re often called in to help with the clean-up after a NATA assessment. That involves working to dig deep to find the real causes of the problems and put in place a sustainable fix that won’t see the problem rear its ugly head again, especially not at the next assessment!

But why wait until NATA discovers your problems? There are a few things you can do:

Remember, you don’t have to do this alone!

People who read this also enjoyed:

 

Get in touch