Who cares about root cause analysis (RCA)? Of course, we all do now it’s in the revised GCP, the ICH E6 (R2) Addendum*. But does it really matter? It’s easiest to think through from the perspective of an example. Consider a hypothetical situation where you are the Clinical Trial Lead on a vaccine study. Information is emerging that a number of the injections of trial vaccine have actually been administered after the expiry date of the vials. This has happened at several sites. Some example actions you might take immediately are – review medical condition of the subjects affected, review stability data to try to estimate the risk, ask CRAs to check expiry dates on all vaccine at sites on their next visit, remind all sites of the need to check the expiry date prior to administering the vaccine. These and many other actions are ones your team could quickly generate and implement and they will likely contain the issue for now. It took no root cause analysis to generate these actions. Could you sleep being confident in the knowledge that the problem won’t recur?
Without RCA, you don’t really know why the problem occurred and so you can’t fix it at the source. All you can do is put in additional checks and as these are implemented reactively, they may not be properly thought through and people may be poorly trained (or not trained at all) on the additional checks. We also know that while checks are valuable in a process they are not 100% effective when carried out by people. In this example we can be sure that the pharmacist dispensing and the nurse administering the vaccine have been trained to check the expiry date and yet we still have cases where expired vaccine has been administered. Do we really think that reminding the pharmacist and nurse is going to be enough to fix the problem forever? In a future blog, I will describe a powerful technique for RCA but for now, imagine you had managed to carry out a root cause analysis on this situation.
What you might discover in carrying out a RCA is that there is no defined process for informing sites of expired vaccine and requiring them to quarantine it. Or perhaps that the expiry date is written in American date format but being read in European format (3/8/16 being 8-Mar-2016 or 3-Aug-2016). Whatever the actual root cause, by finding what it is (or they are) you can start to consider options to try to stop recurrence. And with additional checks you could look for early signals in case these actions are not effective. By taking these actions, would you be more likely to sleep at night?
Think you know about RCA? In my next blog I will reveal why the Five Whys method we’re always told to use is not good enough for a complex situation such as this. And later, I will provide a description of a powerful technique for RCA that seems to be seldom used. If you want to hear more, please subscribe to my blog on the left of the screen. All comments welcomed!
And did you notice that I haven’t mentioned CAPA once (until now!)
* Section 5.20.1 Addendum: “If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.” [my emphasis]