In any industry, quality is the building block of everything. People are relied on to deliver the services and products customers expect and need. This is especially so in biopharmaceuticals. But what happens when things go wrong? And what makes them go wrong in the first place?
The reasons are myriad but ‘human error’ is often cited as the cause of problems such as accidents, product recalls and patient safety issues. Unfortunately, a human error is not seen as an opportunity to learn, but as something that drains time, money and resources.
Changing this mindset is crucial to a better understanding of how success and failure happen within an organization, and how to improve its potential to anticipate, monitor, respond and learn – the cornerstones of resilience.
As an industry, biopharmaceuticals is immature when it comes to the integration of human performance into operations. Building on BioPhorum’s ‘blue-sky’ description of human performance from 2018, the Human Performance Workstream has written a paper called Shared risk management in complex systems: ‘blue-sky’ human performance and how to get there. The aim of this article is to accelerate the industry’s maturity by building a greater understanding of what is desired and explaining how to get there. Human Performance is believed by many companies in our industry to be a focus on human error reduction, where work outcomes will improve by adding more requirements and coercing people to try harder to be infallible. This archaic approach is not sustainable today and is not Human Performance.
This paper is specific to our industry. Companies are not likely to have success by copying a program from another industry, such as nuclear. We have provided guidance that has worked within our industry and the unique regulatory space we operate within. If you think you’re doing Human Performance and it doesn’t look, feel and sound as we have described in this paper, then you are not there yet.
‘Blue-sky’ human performance
The paper summarizes the team’s shared experience over the last few years and discusses how the performance of teams and whole operations can be improved through investigations and learning, proactive learning and monitoring performance.
Its key points can be summarized as:
- Error is normal – even the best people make mistakes
- Blame fixes nothing
- Learning and improving are vital – learning is deliberate
- Context influences behavior – systems drive outcomes
- How you respond to failure matters, how leaders act and respond counts.
Blue-sky vision of human performance takes time and patience to implement properly and must be viewed as a fundamental change to how an entire organization operates. It requires a transformation of the organization’s systems and thinking over a period of several years. The paper provides proven guidance and a case study of why one company’s standard approaches to root cause analysis were ineffective at reducing repeat events – both minor events but also significant ones that caused a loss of product and production time, such as contaminations. It discusses how the culture of the company changed from one of ‘it only happened once’ with weak corrective and preventive actions, to one where ‘human errors’ were only considered symptoms of wider system-level problems in the organization.
The business environment is changing and yet mental models created years ago of what good problem-solving looks like, and how they drive overall performance are still used. Human Performance is the way to make a shift towards systems thinking. Without making this change, organizations may fail to keep up with the increasing complexity of the environments in which they work, and the environments they create.