November 30, 2022 | Mark Paradies

CAPA Requirements for Root Cause Analysis

CAPA - Corrective and Preventive Actions

Inadequate Root Cause Analysis for CAPA – Why?

What is one of the most frequent findings in audits of drug manufacturers around the world? Inadequate investigations and root cause analysis of non-compliance and manufacturing issues. The result? Failed corrective and preventive actions (CAPA). Thus it should be obvious that advanced root cause analysis that includes all the fundamentals should be a part of any CAPA program.

Why do so many audits identify weak or non-existent root cause analysis as a finding? Because much of the advice given to pharmaceutical manufacturers, medical device manufacturers, and food suppliers is either inadequate or just plain wrong.

Let’s look at two examples of this bad advice given by consultants or so-called industry experts…

1. Experts Say That 5-Whys is a Good Root Cause Analysis Technique  

Let’s just start with the obvious. 5-Whys is an inadequate root cause analysis technique.

I know this statement will upset many consultants/experts that recommend using 5-Whys, but I think they are providing advice that should be called “root cause analysis malpractice.”

Why is 5-Whys inadequate? The primary reason is that it doesn’t help investigators (who are usually staff members at the company having the problem) go beyond their current knowledge. The people who created the system that is failing are using their knowledge to ask “Why” five times, and they are supposed to discover why their system is failing. That sounds unlikely.

Read the example (not from the pharmaceutical industry) of how 5-Why’s compares to advanced root cause analysis at THIS LINK. The expert that was performing the 5-Why analysis missed several lines of questioning that, when followed up, could have led to several excellent ideas to improve performance and avoid future failures. These lessons learned were not missed when using advanced root cause analysis.

Next, read this article from Quality Progress:

It provides ideas why simple “cause-and-effect” like 5-Whys just doesn’t cut it when looking for the causes of human performance and complex equipment reliability issues.

Finally, ask yourself this question about investigations you have seen that used 5-Whys …

How many times have you seen “human error”
listed as a root cause of a quality issue?

If you still think that “human error” is the root cause, perhaps you need to read these two articles…

By this point, you should probably be doubting the expert advice about using 5-Whys to find root causes. This bad advice alone is a major reason that people don’t meet the regulator’s CAPA expectations.

But there is another major reason that companies don’t meet their regulator’s CAPA expectations…

2. Experts Say That You Don’t Need to Investigate Every Quality Failure

Only investigating the most serious quality issues seems logical. But the problem with this advice is that most manufacturers aren’t investigating important quality issues because they don’t know there are important lessons to learn BEFORE they perform a root cause analysis. Therefore, many less serious quality issues aren’t investigated despite the fact that the investigations could reveal important improvement ideas that would prevent serious quality issues in the future.

That’s why we wrote this article about Apparent Cause Analysis…

At a minimum, you must investigate precursor incidents to major quality issues. The hard part is to decide which incidents are worthy of an investigation and root cause analysis.

For safety incidents, we suggest using an evaluation of the energy source.

But for quality and process safety incidents, one must evaluate the Safeguards and decide how many Safeguards failed and how many Safeguards worked, and if the remaining Safeguards were adequate for the risk that was being managed.

For a biopharmaceutical example, see THIS LINK.

Since we wrote about the example in the link above (2016), we have simplified this process even more by developing a Quality Causal Factor Worksheet for quality issues. (A partial worksheet is shown below.)

Quality Causal Factor Worksheet
Copyrighted by System Improvements. Used by permission.

Using this worksheet in conjunction with a SnapCharT® Diagram can help management make an informed decision about what incidents are worthy of investigation.

Root Cause Analysis for a Superior CAPA System

The TapRooT® 5-Step Process for investigating low-to-medium risk incidents is shown below. The first part of the process helps you decide if the incident is worth investigating. When you decide to investigate the incident more thoroughly, steps 2.3-2.5 help you find the true root causes of a quality issue and develop effective corrective and preventive actions.

Simple TapRooT® 5-Step Process

Probably the biggest help to investigators in finding the root causes of the Causal Factors associated with an incident is the TapRooT® Root Cause Tree® Diagram and Root Cause Tree® Dictionary.

TapRooT® Root Cause Tree®

The Root Cause Tree® Diagram and Dictionary guide investigators beyond their current knowledge by providing expert questions about human errors and equipment failures.

Root Cause Tree® Dictionary

To find out more about how this guidance works, see…

Learn More About TapRooT® Root Cause Analysis and CAPA

The first step to learning more about TapRooT® Root Cause Analysis is to attend one of our courses. CLICK HERE for an outline of our courses and CLICK HERE for the upcoming public course dates and locations. Or, if you want to schedule a course at your site or a virtual course, CONTACT US.

You may also want to learn more about how our patented cloud-based software can help your team perform a root cause analysis more efficiently and effectively. Again, CONTACT US, and we will set up an executive briefing.

Finally, we sponsor an annual Global TapRooT® Summit to help people across and within industries and across professions share best practices. The 2023 Global TapRooT® Summit includes a CAPA Best Practices Track. This is a great place to network with industry leaders from around the world and learn their ideas to improve root cause analysis and CAPA. Don’t miss this upcoming event being held on April 24-28 at the Margaritaville Lake Resort, Lake Conroe, near Houston, Texas.

2023 Global TapRooT® ® Summit Brochure
Root Cause Analysis, Root Cause Analysis Tips
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