Let’s do a magic trick. Through this computer screen, I’ll read your mind…
Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick. Every company wrestles with human error. We know humans have error rates – we’re not perfect. But how many is too many?
I recently spoke with someone who said a whopping 58% of their root causes were identified as human error. Average run rates at companies seem to hover in the neighborhood of 25% – and I was on the receiving end of a 483 observation in a company where this was the case. So I can say with certainty that our target should be assigning a “human error” root cause to only a small quantity of deviations.
However, industry and the regulators seem to have differing expectations on this point.
How Do Industry And Regulatory Expectations And Approaches Differ?
Existing regulation supports that industry regulators expect only a small quantity of deviations to result from human error. From Chapter 1 of the European GMPs:
1.4 (xiv): …Where human error is suspected or identified as the cause, this should
be justified, having taken care to ensure that process, procedural or system-based
errors or problems have not been overlooked, if present…
Our regulators see human error as a last resort. Their expectation is that you can - and have - eliminated any possible process issues and confirmed that the individual had everything they needed and simply wasn’t focused.
Industry sees human error as a first-line response. We almost assume our processes, procedures and training are bulletproof, and the issue must have resulted from someone not paying appropriate attention to what they were doing at the time. When we do look at our training, procedures or process, we often verify that they make sense to us – the reviewer. And then we retrain the operator on the same process or procedure, using the same training process – quickly! – so they can return to performing the task again.
How Should We Approach Human Errors?
To illustrate what we’re expected to do, let’s take a fairly common event: Failure to follow procedure. Under many circumstances, we don’t give this more than a glance before categorizing it as human error. And it very well may be. But let’s consider other possible areas before rushing to that decision. Asking one simple question - “Why wasn’t the procedure followed?” - can lead to many different underlying reasons, such as:
Worse, our process for changing procedures has its own challenges: Too many reviewers, difficult change processes, people who hold their changes to a procedure until someone else initiates a change and then try adding their changes on, and more. So we put off changing procedures that we know need help because of the difficulty of the change process.
Prior to categorizing the failure as a human error, assess your procedure for the following:
Some companies still do only read and understand training when more is needed. Others perform OJT, but don’t assess the trainee prior to releasing them to perform. Yet others don’t provide supporting information the trainee needs to perform the task.
And there’s a more fundamental piece, related to the GMP foundation we provide. People must understand GMP expectations enough to see that the only acceptable way of performing a task is as documented in the procedure.
Prior to calling the failure a human error, ask these questions of your training program:
If we make it easy for someone to make a mistake, they will. We need to make it easy for someone to do the right thing.
Lean and human error reduction activities should be used to find extra, wasted efforts and error-prone activities and design those out of the processes. Too often, these processes are used to justify cost-cutting, making things worse.
Again, prior to deciding the failure was human error, consider the design of the process the operator was performing. Ask these and any other applicable process design questions about the failure:
If operators multitask, or are frequently interrupted, the likelihood of an error increases due to multiple shifts of focus. Sometimes this will be raised as a concern, but sometimes not – especially in resource-constrained environments where operators feel concerns have fallen on deaf ears.
Management plays a significant role in this situation. The assignment and alignment of work and projects, timing of meetings, using operators to provide training, and more affect how an operator works and their focus on tasks being performed. While these are human error situations, they are driven not by the operator, but by the manager’s decisions and how much functional oversight and process management takes place.
Once again, prior to categorizing the failure as human error, ask questions like these about the situation:
The Power Of “Why?”
A simple root cause analysis tool called “5 Whys” is a quick, easy way to identify the underlying conditions leading to a deviation. A very brief version was presented in the above content. We asked the first of the five “Why?” questions – and raised possibilities beyond human error that could have caused the failure with one simple question.
Problems appearing as human error should always be explored further. Human error often isn’t the root cause – it’s a symptom of an underlying problem. Using the “5 Whys” will help identify the underlying causes of the problem. Through asking “Why?” repeatedly, you begin to understand what led to the problem – and ultimately identify the root cause. It generally takes a chain of five “Why?” questions to get to root cause.
A “5 Whys” analysis can help you meet the regulatory expectation of assessing whether process, procedure, or system based problems contributed to a human error. If you go through the analysis and find nothing but the operator making an honest error, you can be confident in – and able to support - your assessment of human error as the root cause.