In an earlier post, I described 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. I then described actions you might take without the need for root cause analysis (RCA) such as – 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. So if you were to now go through the time and effort of a DIGR® RCA and you still end up with these and similar actions, why did you bother with the RCA? RCA should lead to actions that tackle the root cause and try to stop the issue recurring – to help you sleep at night. If you or your organization is not going to implement actions based on the RCA then don’t carry out the RCA. A couple of (real) examples from an office environment might help to illustrate the point.
In a coffee area there are two fridges for people to store milk, their lunch etc. One of them has a sign on it. The sign is large and very clear “Do not use”. And yet, if you open the fridge, you will see milk and people’s lunch in it. No-one takes any notice of the notice. But why not? In human factors analysis, the error occurring as people ignore the sign is a routine non-compliance. Most people don’t pay much attention to signs around the office and this is just another sign that no-one takes notice of. Facilities Management occasionally sends out a moaning email that people aren’t to use the fridge but again no-one really takes any notice.
What is interesting is that the sign also contains some root cause analysis. Underneath “Do not use” in small writing it states “Seal is broken and so fridge does not stay cold”. Someone had noticed at some point that the temperature was not as cold as it should be and root cause analysis (RCA) had led to the realisation that a broken seal was the cause. So far, so good. But the action following this was pathetic – putting up a sign telling people not to use it. Indeed, when you think about it, no RCA was needed at all to get to the action of putting up the sign. The RCA was a waste of time if this is all it led to. What should they have done? Replaced the seal perhaps. Or replaced the fridge. Or removed the fridge. But putting a sign up was not good enough.
The second example – a case of regular slips on the hall floors outside the elevators – including one minor concussion. A RCA was carried out and the conclusion was that the slips were due to wet surfaces when the time people left the office coincided with the floors being cleaned. So the solution was to make sure there were more of the yellow signs warning of slips at the time of cleaning. But slips still occurred – because people tended to ignore the signs. A better solution might have been to change the time of the cleaning or to put an anti-slip coating on the floor. There’s no point in spending time on determining the root cause unless you think beyond the root cause to consider options that might really make a difference.
Root cause analysis is not always easy and it can be time consuming. The last thing you want to do is waste the output by not using it properly. Always ask yourself – could I have taken this action before I knew what the root cause was? If so, then you are clearly not using the results of the RCA and it is likely your action on its own will not be enough. Using this approach might help you to determine whether “retraining” is a good corrective action. I will talk more about this in a future post.
Here’s a site I found with a whole series of signs that helps us understand one of the reasons signs tend to be ignored. Some of them made me cry with laughter.
Photo: Hypotheseyes CC BY-SA 4.0
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