human error

Human Error: Don't Blame People - Fix the System because...

NSF International, Pharma Biotech

Ever poured coffee into a tea pot, put petrol in a diesel car, written on a white board with a permanent marker, turned up at the wrong hotel for a conference or forgotten the name of your boss? Well, I’ve done them all. I even managed to get onto the wrong flight once. That took some doing. As they say ‘To Error is Human’.

Well, if you're serious about error prevention read on to get your error reduction questions answered, guidance on your ‘Six to Fix’, access to free ‘error reduction’ resources and additional support to help drive down errors

Let’s start with a ‘Top Ten’ Error Quiz to get the neurons firing. Answer with a simple 'Yes' or 'No'

> 1. - Are a majority of your deviations or mistakes put down to ‘human error’?

> 2. - Do your preventive actions focus on things like ‘re-training’, additional checks, adding more detail to instructions or, when all else has failed, disciplinary action? Who knows, even promotion (yep, I’ve seen this as well)

> 3. - Do you think our Regulators are happy with errors happening again and again?

> 4. - Do most of your error investigations focus on your people, not the ‘system’ or working conditions they have to endure?

> 5. - Do you believe there is no such thing as a single ‘root cause’ to any problem?

> 6. - Does a culture of ‘blame’ increase the risk of errors and mistakes?

> 7. - Does complexity increase error rates?

> 8. - Do you think most errors are due to systems, procedures and the leadership who created them?

> 9.- Is your training predicated on the belief in ‘trained perfectibility’? In other words once trained you're expected to get it right?

> 10. - Do you think people are naturally error prone and will always make mistakes…and there is nothing you can do about it? I know what my long suffering wife would say

NOW THE ANSWERS:

Q1. Lots of ‘human error deviations’? Answer = ‘Yes’

I’m afraid so. In our experience ‘root cause – human error’ is the conclusion of convenience for a good few incident reports. Why? Well, it’s quick and easy for sure. It also satisfies those who believe in ‘The Person Model’ of human error. This is the most widely held view that places the origins of mistakes squarely between the ears of people at the sharp end. ‘The product of forgetfulness, inattention, distraction, ignorance and other wayward mental processes’ (Prof. James Reason) The actions that follow usually involve retraining, naming, shaming and writing more procedures. This approach focuses on the person, not the system or environment. Although quick, easy and emotionally satisfying it’s also very wrong. The illusion of control it creates is false and potentially dangerous. More later…

Q2. Lots of checks, retraining and the like? Answer= In our experience … ‘Yes’

If you focus prevention purely on ‘The Person’, a few of things are guaranteed. The incident will happen again, risk will increase and culture of fear and blame will creep in (the biggest risk of all). Once blame becomes the norm, mistakes get hidden and go unreported. After all, who likes pain and embarrassment? As soon as ‘error’ becomes a dirty word you're on the slippery slope to a potential crisis. It’s not if, more like when. Few set out to create a blame culture (why would you?) but it can creep in unnoticed. Poor KPI’s, ineffective communication, invisible shop floor management all help 'blame' to sneak in.

Q3. Are Regulators Happy? Answer= Emphatically ‘NO’

Regulators, many of whom have attended our course Human Error Prevention, want you to fix problems and minimise risk. Not treat the symptoms and move on. An increasing number of companies have been cited for poor investigations and repeat incidents. If you’ve concluded ‘root cause – human error’ you had better have a good reason. If you have lots of human error deviations you deserve the criticism and 483s coming your way. As one inspector said to me recently "it seems we’re more concerned about the increased risk than they are".

Q4. Investigations focus on people? Answer= in our experience ‘Yes’

A recent report from the highly respected Institute of Medicine endorsed the opposite approach to ‘The Person Model’. Namely ‘The System Model’ approach to error investigations. The premise here is that humans are fallible and that errors are to be expected. Even in the best organisations. Errors are seen as the consequence not the cause. The starting point of any investigation. Rarely its conclusion. The ‘System’ approach to investigations is adopted by those companies serious about removing the real ‘error traps’ that management unintentionally set by introducing complexity, poor communication, inappropriate KPIs, selecting suppliers on price alone…the list is endless. Ironically many of these exist in your Quality System which is meant to protect your patients and your legacy. Not increase error risk.

Q5. Root Cause: Answer = There is no such thing as 'Root Cause'!

Every mistake, big and small, is always due to multiple contributing factors that all come together to form the ‘error chain’. When investigating errors you must dig below the surface to discover, and remove, the many contributing factors that exist. So, think error chain and multiple causes and ban the term ‘root cause’ for ever. It’s a myth.

Q6. Does a Blame Culture make a difference? Answer = You bet

We humans are really quite simple creatures. Part of our makeup is to feel liked, respected and safe. When criticised, named, shamed and blamed we are conditioned to either fight or run away. Both career limiting. In a blame culture there are a few other options to help avoid the pain and ignominy of criticism. Just say nothing or tell management only the good news or just hide problems that could be painful. All perfectly understandable really. Leaders are the architects of company culture and it’s their job is to create one that allows problems to be raised, discussed and solved…without fear.

Q7. Do Complexity and Error go hand in hand? Answer = 100% Yes

Our 21st century brains are virtually identical to those of our ancestors. All they had to worry about was staying alive and reproducing. They didn’t have to endure complex SOPs, overcomplicated batch records or operating processes that require multitasking which, by the way, is a neurological impossibility. As complexity increases so does confusion, followed by errors. Want to reduce error rate? Just strip out complexity. Want to know how?...just carry on reading.

8. Do ‘systems’ create most errors? Answer: Yes

SOPs with just words, batch records with multiple checks, ineffective training, poor change control, overreliance on contractors, 12 hour shifts, a 20 page SOP for Deviation Investigations are all examples of 'error traps' set by leadership, albeit unintentionally. I could have gone on…my list of system 'error traps' reads like ‘War and Peace’. Want to know how to find these and fix them? Read on…

Q9. Once trained do you expect people to get it right? Answer = Ermm…

We all know the correct answer is NO. Training alone doesn’t work. However its effectiveness can be dramatically improved by taking the 10/20/70 approach and by focussing on the ‘habit loop’. More later…

Q10. Should we just accept that people will always make mistakes? Answer = No, not really

We all make mistakes and there is little we can do to change the neurological processes that created them. However, we can change the environment, the error ‘catalysts. We can adopt good user centred design, wage war on complexity, put supervisors back on the line, fix the blame culture, remove the term ‘root cause’ and invest in education not training. The key to it all is to focus on the system not the person. Vital to error reduction is getting leadership connected and visible to the shop floor. Maybe, then, they wouldn’t set so many ‘error traps’

NOW FOR YOUR FREE RESOURCES

> Please join our Human Error Prevention Group on LinkedIn. We created this to act as a forum for discussion and sharing. Problems as well as solutions.

> Please have a look at the following webinars on our website:

Reducing Human Error - 5 Key Action Steps

Human Error Prevention

Changing Behaviors in the Workplace

> These are also available on You Tube

Improving CAPA Effectiveness:

Quality Habits:

Human Reliability Improvement: Reducing Documentation Errors

Free Webinar: Human Reliability Improvement - Why Categorize and How to Categorize Human Error

NOW FOR YOUR ‘SIX TO FIX’

> Ban the term ‘root cause’. It’s a myth. Focus on removing the multiple factors that accompany every error or mistake. Break the error chain.

> Make sure your investigation focuses on ‘The System’, not ‘The Person’.

> Remove blame and you will be fine. Don’t and you won’t.

> If you haven’t started your war on complexity already, start now. You can’t afford to lose it.

> Get your leadership on the shop floor. You can’t afford anymore error traps.

PLEASE use the free resources above. We really want to help you About the Author

Martin Lush has over 30 years’ experience in the pharmaceutical and healthcare industry. He has held senior management positions in QA, manufacturing, QC and supply chain auditing and has conducted audits and education programs for many hundreds of companies in over 25 countries.

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