People in Pharma Blog

CAPA: Human error – root cause, or symptom?

I find that I can really focus on my reading when I’m in coffee shops … a nice latte, with a touch of vanilla, and off I go. I was in one of my favourite spots last week when the owner, a middle aged gentleman, brought me my order and noticed the title of the book on the table in front of me: ‘Prevention of Human Error’.
“That’s an interesting title” he said.
“Yes” I replied “It’s about understanding how people make mistakes at work. Depending on the work they are doing” I said “even a simple mistake could be disastrous”
“I can save you wasting your time reading that” he said “Just pay them more!”
“Do you really think that would cut out errors?” I asked.
“Definitely, absolutely no doubt about it”
We chatted about this for a while, and I suggested that the issues surrounding human error are rarely as straightforward they might at first seem to be. But he was having none of it – he was adamant that such errors were all about paying attention, and that attention could easily be enhanced by appropriate motivation (financial, in his case).
This simplistic approach to human error is not uncommon in the business environment either, but on reflection it doesn’t ring true. One would have thought that a pilot would be fairly motivated not to fly his or her airliner into a mountainside, but it is not uncommon to read about air crashes to which pilot error is assigned as a primary cause. If properly trained, operators working in a pharmaceutical environment will be very aware of the potential effects on patients that any of their mistakes could have; sufficient motivation one would have thought. Yet in the pharmaceutical business it is not unusual for human error to be stated as the root cause in CAPA investigations, often followed by ‘retraining’ as a preventive action.
But is ‘human error’ really that simple? Does retraining solve the problem? Or is the error not even a contributory cause, let alone a root cause, but merely a symptom of a deeper systemic issue?
Often the biggest challenge we have in addressing human error is getting past preconceptions which scream ‘careless’, ‘not committed’, ‘silly mistake’, and so on. Until we do, the effectiveness of CAPA solutions for ‘human error’ issues will continue to be very limited.