August 8, 2018 | Mark Paradies

What’s Wrong with Pharmaceutical Root Cause Analysis?


I was forwarded a copy of an interesting letter about American and Canadian Standards Boards with certifying bodies rejecting pharmaceutical quality incident reports because of poor root cause analysis. It stated that 90% of the rejections of reports were due to three types of root causes that were unacceptable (and I quote):

  1. Employee Error / Human Error / Operator Error OR anyone else who made an error is not an acceptable root cause – Was the training ineffective?  Was the procedure too vague?
  2. Misunderstood the requirement / Did not know it was a requirement / Our consultant told us this was ok OR any other misunderstandings is not an acceptable root cause.  Was the training effective?
  3. We had a layoff / Mona was on maternity leave / we moved locations / we scaled back production / we are still closing out Wayne’s 40 deviations from the last audit OR most other employee or business conditions are not acceptable root causes  They are DIRECT CAUSES.

The letter proposed four rules to follow with all future submissions:

  1. RULE #1:  The root cause can not be a re-statement of the deviation.  Example:  Deviation – Company XYZ did not document Preventive Actions as required by procedure.  Root Cause – We did not document Preventive Actions as required by the procedure.
  2. RULE #2:  There can not be an obvious “Why” that can be easily answered to the provided root cause – in this case they have not gone deep enough.  Example: Root Cause – The purchasing coordinator made a mistake and did not check to see if the supplier was approved.  Obvious “WHY” Was the training effective?  Did the procedure provide enough detail in this area?
  3. RULE #3:  The root cause can not be a direct cause.  Example:  Deviation – There were a number of internal audits scheduled for 2008 that were not completed.  Root Cause – We had a layoff and we did not have enough Internal Auditors to conduct the audits.
  4. RULE #4:  The root cause is a brief description of the cause of the problem.  We do not want any long stories regarding direct causes or what they are doing well even though this happened or who said what.  This is un-necessary detail and only adds confusion.

Wow! I would have thought this guidance would not be necessary. Are responses to quality incidents really this poor? Or is this letter a fake?

No wonder TapRooT® Users have no problem getting approvals for their root cause analysis. None of these problems would happen with any investigation using TapRooT®.

Why would TapRooT® Users never stop at the three causes listed above? Because they would understand that some are Causal Factors (the start of the root cause analysis) and they would have guidance provided by the Root Cause Tree® Diagram to help them find the real, fixable root causes of human performance and equipment failure related problems. This includes analyzing things like “internal audits not completed”; “human error”; and “misunderstood requirements.”

In addition, the TapRooT® Software helps investigators develop concise custom reports that only includes the details needed to understand what happened, how it happened, the root causes, and the effective corrective actions needed to prevent recurrence.

If you are in the pharmaceutical industry and you want to stop having problems with root cause analysis and want to start having effective investigations, root cause analysis, and fixes for problems, attend our TapRooT® Training and learn how simple advanced root cause analysis is.

Root Cause Analysis
Show Comments

Leave a Reply

Your email address will not be published.