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Root Cause Analysis for CAPA: 5 Steps to Inspection Readiness

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In today’s fast-paced regulatory landscape, being inspection-ready isn’t optional—it’s essential. A strong Root Cause Analysis (RCA) process can mean the difference between repeat deviations and long-term excellence. RCA is more than just a quality requirement—it’s the foundation of an effective Corrective and Preventive Action (CAPA) system.  Here are five (5) steps to establishing a solid RCA process:

Step 1: Define the Problem Accurately

Every strong CAPA begins with a clear, documented problem statement. Avoid vague terms like “operator error.” Instead, outline:

  • What occurred

  • Where and when it happened

  • How it was detected

Need help framing your investigation? Check out Understanding the CAPA Process to align with industry expectations.

Step 2: Collect Supporting Data

Gather all relevant evidence: audit logs, deviation reports, interviews, and batch records. Thorough documentation not only strengthens your RCA—it shows FDA inspectors you take quality seriously.

Step 3: Identify and Verify the Root Cause

Use tools like:

  • 5 Whys

  • Fishbone (Ishikawa) diagrams

Be honest: are you solving the real problem, or just the visible one? Learn how to go deeper with Getting to the Core of the CAPA System – The Root Cause Analysis.

Step 4: Build a Robust CAPA Plan

Once root cause is verified:

  • Correct the immediate issue (e.g., isolate affected materials, issue a stop order).

  • Corrective Action: Revise SOPs, retrain staff, and automate error-prone steps.

  • Preventive Action: Introduce monitoring dashboards, conduct follow-ups at 3- and 6-month intervals.

Make sure your plan is SMART: Specific, Measurable, Achievable, Relevant, and Time-bound.

Step 5: Monitor and Sustain Results

Your CAPA is only as good as its outcome tracking. Monitor metrics such as:

  • Repeat deviation rate

  • CAPA closure time

  • Training effectiveness scores

Regular reviews don’t just keep your system clean—they give you confidence during unannounced audits.

Pro Tip: Conduct a CAPA Dry Run

Treat one of your internal issues like a mock FDA audit. Document each step from problem definition through CAPA closure. Then evaluate: Would this satisfy an inspector? This exercise trains your team and uncovers process blind spots—before an actual audit exposes them.

 

 

Build Your Inspection-Ready Toolkit

Root Cause Analysis isn’t just about solving a problem—it’s about building a culture of prevention.

✅Ready for a little challenge? Here’s your next step:
Take 30 minutes this week to walk through your last deviation or audit finding using the full RCA-to-CAPA lifecycle.

Then ask yourself:

  • Did we stop at the symptom—or get to the true root?

  • Have our corrective actions actually prevented recurrence?

  • Would this stand up to an FDA inspection or internal audit today?

💬 We want to hear from you!
Reply to this article with your biggest challenge when applying RCA or sustaining preventive actions. Your insights could help shape our next guide or training tool—and help others improve, too.

And if you haven’t yet, explore these next:

Together, we’re building smarter systems, stronger teams, and inspection-ready organizations—one finding at a time.

Getting to the Core of the CAPA System – The Root Cause Analysis

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You have just undergone an audit and discovered a gap in your process.  What’s the next step?  The key to inspection readiness is having an effective CAPA system that not only correct the issues but also prevent them from happening again. Only by identifying the root cause of the problem will you be able to prevent it from happening again.

When it comes to diagnosing the source of an issue in a fast-paced industry, speed is important. As a result, many departments rely on the tried-and-tested procedures of Root Cause Analysis (RCA) and Corrective Action Planning (CAPA) to identify and prevent problems. Here’s a closer look at Root Cause Analysis.

What Is a Root Cause Analysis?

Root Cause Analysis (RCA) is a technique for determining what, how, and why an event occurred so that preventative measures can be adopted. Data collection, root cause identification and execution are all part of it. To put it another way, RCA is a set of procedures that allows you to delve behind the surface of a problem to uncover causal pathways that lead to the problem’s underlying root causes.

What Are the Root Causes?

To comprehend fundamental causes, we must first comprehend what the issue is in the first place. A problem could be a divergence from customer specifications or another type of non – compliance at its most basic level.  The root causes of these issues are the precise, root factors that can be properly identified, are within the company’s authority to address, and result in effective solutions to prevent relapses.

How Are RCA and CAPA Connected?

The CAPA as discussed before,  is the action phrase, whereas if RCA is the subject. The root cause is what is causing the problem, and the CAPA is what will be done to fix it and keep it from occurring again.

The 5 Why’s in RCA

The 5 Whys is a simple yet powerful cause-and-effect method for determining the fundamental cause of a problem. You’ll begin by identifying the problem (RCA input), then query why each issue is happening until you find the root cause. Keep in mind that you don’t have to stop at five; in some circumstances, six or seven repeats may be necessary.

The Action Plan

The team must build suitable countermeasures or remedial activities after determining the root cause.  The team should also devise a strategy for putting the solutions into effect. The counter-measures can be divided into two categories:

  • Short-term Action Plan: Countermeasures that can be implemented quickly, usually in less than a week
  • Long-term Action Plan: Long-term or lasting solutions are usually more difficult to implement and may necessitate additional resources. All “long-term” action plans should be completed in less than one month. If not, they should be sent to the Continuous Improvement (CI) team for review.

Conclusion

By discovering the underlying cause and taking action to prevent it from reoccurring, the establishment of a comprehensive, well-planned Root Cause Analysis (RCA) methodology can be extremely beneficial to a department in terms of inspection readiness. Many of the lessons learned during a successful RCA can be applied to similar designs or processes.

Need to strengthen the Root Cause Analysis of your CAPA System? Contact us! We’d love to hear from you to discuss strategies!

 

References

  • Buchholz, V. (2019). What Went Wrong and How To Fix It.
  • Quality-One. (2021). Root cause Analysis (RCA). Quality. Retrieved September 10, 2021, from https://quality-one.com/rca/.
  • Wikimedia Foundation. (2021, July 13). Five whys. Wikipedia. Retrieved September 10, 2021, from https://en.wikipedia.org/wiki/Five_whys.

 

Our Mission and Purpose

The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.

Our History

2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.