BAD Root Cause Analysis is the #1 Cause of Failed Pharmaceutical CAPA
CAPA and Root Cause Analysis
The FDA requires that pharmaceutical manufacturers investigate and resolve quality incidents and prevent their recurrence. This is done by applying a process called CAPA (Corrective and Preventive Action). To develop corrective and preventive actions, pharmaceutical manufacturers should use an advanced root cause analysis system to identify real, fixable root causes that, when fixed, will prevent future quality escapes.
Unfortunately, many pharmaceutical manufacturers use simple, unreliable root cause analysis tools such as 5-Whys or Fishbone Diagrams. Using these simple tools may lead to blame-oriented investigations that yield findings that aren’t the actual root causes. (Read THIS ARTICLE published in ASQ’s Quality Progress for why 5-Whys and Fishbone Diagrams produce substandard results.)
What are examples of root causes that might be unacceptable and result in an FDA Warning Letter? They might include:
- Human error
- Equipment failure
- Poor training
- Bad procedure
While these are problems, they are not root causes. What is a root cause?
Our modern definition of a root cause is:
ROOT CAUSE
The absence of a best practice
or the failure to apply knowledge
that would have prevented the problem
For the history of the definition of the term “root cause,” see THIS LINK.
Two of the main reasons simple techniques like 5-Whys and Fishbone Diagrams aren’t effective in a pharmaceutical CAPA process are that:
- They don’t define what a root cause is.
- They don’t guide investigators beyond their current knowledge to identify true root causes that, when corrected, will prevent the quality issue from recurring.
That is why ineffective CAPA (primarily driven by ineffective root cause analysis and poor corrective and preventive actions) is the leading cause of FDA Warning Letters. (See this LINK for a previous article on this topic.)
Why Do Companies Use Bad Root Cause Analysis?
The simple answer to that question is that techniques like 5-Whys are EASY. And when people don’t have the time and resources to do an investigation right, they might as well use the easy method. Plus, many so-called experts claim these easy techniques are good enough. But the FDA warning letters prove that this advice is shortsighted. These experts haven’t researched root cause analysis and human factors to understand what investigators need for quality root cause analysis investigations.
Should You Improve Your Root Cause Analysis?
Is it time to take action to prevent FDA Warning Letters due to poor CAPA, root cause analysis, and weak corrective actions? Consider attending a 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Course. You will learn to apply a proven root cause analysis system both reactively and proactively to:
- Understand the complete sequence of events of the quality issue.
- Identify all the causal factors that lead to the quality issue.
- Identify the true root causes of each causal factor, being guided by the Root Cause Tree® and the Root Cause Tree® Dictionary.
- Identify systemic issues (generic causes) that allow the root causes to exist.
- Develop effective fixes for root and generic causes guided by the Corrective Action Helper® Guide.
That is the information you need to improve your root cause analysis.
For the complete course outline, CLICK HERE.
To see the dates and locations of all our TapRooT® Training (including the 5-Day TapRooT® Class), CLICK HERE.
To see an example of how the TapRooT® Root Cause Analysis System works, CLICK HERE.
To see Success Stories submitted by TapRooT® Users, CLICK HERE.
Whatever you do, DON’T WAIT! Be proactive! Take a TapRooT® Root Cause Analysis Course and improve your CAPA system BEFORE you receive an FDA Warning Letter.
