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Gerry McAuley is a business consultant and facilitator to the Human Performance Group at the BioPhorum Operations Group.
This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.
This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention. Human performance is both a major challenge and a massive opportunity facing the biopharmaceutical industry today. Human error costs the industry wasted time and money, running into hundreds of millions of dollars each year. Human error causes batch failures, product recalls, and other product quality and patient safety issues; leads to accidents; and can potentially undermine regulator and investor confidence. Unfortunately, the characteristic response to human errors—root cause analysis followed by corrective actions based on worn-out themes, such as “Read and understand the SOP”—rarely succeeds in preventing re-occurrences, or in affecting lasting reform.
Parts I and II of this series discussed how an organisation can begin making the journey to human performance excellence by adapting best practices and learning from the leaders in the field. The recognition that human performance requires a systemic approach to error reduction is essential. Deviations reflect weaknesses in an organisation’s systems, not in its people. Part III of this series explores the key components of human error as well as eight CRITICAL elements of human performance success.
Errors: A Side Effect of Humanity
No one is immune to error. Even the brightest, most talented team member will make an error on occasion. In an industry where there is no room for error, as well as increasing pressure to optimize human performance, however, it is not enough to simply shrug off errors as part of the human condition.
It is possible to manage human error, reduce it to negligible amounts, and sustain exceptional levels of human performance. An understanding of the key components of human error is an essential first step. These components are the foundation upon which a successful human-error reduction program must be built.
Key Components of Human Error
The following underlying truths of human performance form the baseline belief system that all in an organization must agree upon to improve human performance (1): [O’Connor]
CRITICAL Elements of Success
Once a firm understanding of human error has been established, one can begin developing a human performance program. In addition to the fundamentals discussed in the first two instalments of this series, BPOG suggests instilling the following eight CRITICAL elements of success into a human performance program: Communications, Resources, Involvement, Training, Implementation, Compass, Achievement, and Leadership (2).
Communications. Establish a well-structured ongoing communications program that:
Resources. This refers more to people and time rather than a financial investment. There must be sufficient resources dedicated to making human performance happen: for planning, communicating and driving change, for awareness and skills training, for the additional effort in investigating human-error root causes properly, for implementing effective solutions, and for a rolling program of human error workplace audits. Each company and each site should have a lead person in place who not only has human performance in their job description but is also given the time and resources needed to do the work.
There is also a need for managers to support teams to deploy human performance tools effectively and to establish open reporting. Managers should discuss and act on findings and to support organizational learning.
Funds are also needed to implement solutions, such as better visual management, fool-proofing, equipment, and layout changes. For people to believe the message that the organization is serious about preventing errors, these changes should be made a priority by decision-makers and implemented swiftly.
One should also make sure that first-line supervisors are not being overburdened. Human performance cannot just be “something else” to add to their to-do lists without giving them the time and support they need to make things happen. This group, and each individual within it, needs to be managed carefully—they have the most influence on day-in and day-out custom and practice, so engage them fully.
Involvement. Involve and empower people to openly report, act, and make a difference in the organization across functions and disciplines. Ensure that the right people are actively supporting the changes from the start. Get people talking about human performance.
Training. There are many human performance tools to learn and apply, but these are not complex or hard to learn. The challenge is to apply the tools well and so make sure the training is highly practical. If a real work environment is unavailable, simulations may be used. Test and recognize competence, train on and off the job, create short You Tube style videos showing people applying the tools correctly, and have managers and human performance experts coach teams and individuals to use the tools wherever possible.
Implementation. The key issues to implementing a viable human performance program include:
Compass. Know where the company is heading and which bearings will show that the company is on track. KPIS and leading indicators use formal and informal, quantitative and qualitative assessments to determine where one is and if one is moving off track and need to realign activities accordingly. Track progress against internal and whole industry benchmarks.
Achievement. Achieving results and showing the return on investment from reductions in human-error events in the quickest possible time is what matters. Do not, however, overlook spin-off results, such as the way operational processes and people benefit in other ways from the use of human performance tools and the higher engagement levels that successful open reporting brings.
Leadership. Leadership at all levels plays an enormous role in ensuring that the human performance journey is successful and sustained. Leaders should be aware of the following:
Where Does This Road End?
The road to human performance excellence is not an easy one, but it is one that offers great rewards to those who travel it. In truth, there is only one end—excellence—and that is a continuous journey, as excellence once reached then needs to be sustained. But it is possible. Take, for example, human performance in practice at one nuclear power plant in the United States: it completed 2013 with no events, errors, or injuries. That amounts to approximately 3 million person hours without a lost time OSHA injury and 365 days without a failure to supply power. Just imagine 300 + days without a batch failure or just a dramatic reduction in everyday deviations and you get the picture.
The road is smoothed by elements such as open reporting systems, thorough incident investigation processes,
great human performance coaching and training, and a ‘just’ culture. Most of the concepts and tools are easy to grasp and practice in training before applying every day. It is only through the conscious, relentless application of the tools, in an environment that addresses why the system enables errors to occur and sets out to fix the system, not the person, that real organizational learning and benefits are achieved.
Human performance is in so many ways a move beyond compliance to effectiveness; as such, it complements GxP principles. Get it right and the risk of catastrophic events becomes minuscule, while performance and productivity soars—that’s what makes it a road worth travelling.
1. P. O’Connor and I. Koegh, Irish Med J., 104(1):5-6 (2011).
2. A. Eaton and S. Phillips, Sustaining Lean Healthcare Programmes – a practical survival guide (Ecademy Press Limited, 2008), adapted with the permission of the authors.