No Blame – Why is it so Difficult?

I have written before about the importance of removing blame when trying to get to the root causes of an issue. To quote W Edwards Deming, “No one can put in his [/her] best performance unless he [/she] feels secure. … Secure means without fear, not afraid to express ideas, not afraid to ask questions. Fear takes on many faces.” But why is it so difficult to achieve? You can start a root cause analysis session by telling people that it’s not about blame but there’s more to it than telling people.

It’s in the culture of an organization – which is not easy to change. But you can encourage “no blame” by your questioning technique and approach too. If significant issues at an investigative site have been uncovered during an audit, the easiest thing might be to “blame” the CRA. Why didn’t he/she find the problems and deal with them earlier? What were they doing? Why didn’t they do it right? If I was the CRA and this appeared to be the approach to get to root cause, I certainly would be defensive. Yes, I got it wrong and I need to do better next time. Please don’t sack me! I would be fearful. Would it really help to get to the root causes?

Would it be better to start by saying that QC is not 100% effective – we all miss things. What actually happens before, during and after a monitoring visit to this site? Are the staff cooperative? Do they follow-up quickly with questions and concerns? And the key question – “What could be done differently to help make it more likely that these issues would have been detected and dealt with sooner?” This is really getting at the Gilbert’s Behavior Engineering Model categories. Are site staff and CRA given regular feedback? Are the tools and resources there to perform well? Do people have the right knowledge and skills?

This is where you’re likely to start making progress. Perhaps the site has not run a clinical trial before, they are research-naïve. We haven’t recognised this as a high risk site and are using our standard monitoring approach. The CRA has limited experience. There’s been no co-monitoring visit and no-one’s been reviewing the Monitoring Visit Reports – because there’s a lack of resources due to high CRA turnover and higher than expected patient enrollment. And so on and so on…To quote W. Edwards Deming again, “Nobody goes to work to do a bad job.”

Don’t just tell people it’s not about blame. Show that you mean it by the questions you ask.

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Text: © 2019 DMPI Ltd. All rights reserved.