Making pharma ergonomic

There is a solution to daunting compliance issues, says Dr Brian Edwards, and it is a very human one at that…

The pharmaceutical system is struggling with ever-changing regulations, under-resourcing, increased costs and serious criticism concerning transparency resulting in mistrust. If that was not enough, for a company who wishes to be truly global, they are faced with a changing pharmaceutical environment with greater patient involvement, more and more digital technology, the adoption of personalised medicine, incorporation of real world evidence sources, concerns about product quality and complicated supply chains.

All these changes are occurring under close media scrutiny and are moving at different speeds. Regulations cannot possibly keep up to date. For those aiming just to comply, they will struggle to succeed especially as such an approach is no guarantee of safety. Part of the problems is failure to define the complexity of the system and design processes which are evidenced based, adaptable and flexible for those who work in them. The lack of training about working and coping in complex systems is notable. What a company needs is a future system which needs to be flexible and adaptable to change using robust scientific methodologies. But surely we are doing all we can do aren’t we? The reality is that we have systematically ignored organisational science where there is now a mass of evidence about how to improve systems.

Medicine management

We now accept the importance of a quality management system supporting the lifecycle of a medicine. However, this requires an understanding of the psychological, social and organisational factors that influence quality from a systems perspective and how the evidence about ‘human factors’ can be applied.

The challenges of the pharmaceutical system can only be fully understood with a thorough understanding of how people act within and shape system performance. Ergonomics – or human factors – is the scientific discipline concerned with understanding the interactions among humans and other elements of a system, and the profession that applies theory, principles, data, and methods to design in order to optimise human well-being and overall system performance. The key human factors concern decision-making, situational awareness, leadership, communication, error management, personality and behaviour.

The term ‘human factors’ itself can be misleading and may result in fundamental misunderstandings. ‘Human factors’ can sometimes be mistakenly equated with ‘training’, ‘team training’, ‘non-technical skills’ or ‘soft skills training’ and confused with strategies that are intended to change human behaviour. When a review of non-compliance leads to a corrective action plan where the conclusion is that the ‘root cause’ is ‘human error’, it is typical for organisations to try to modify the behaviour of the individual or group through retraining rather than correcting human behaviour.

Human Factors and ergonomics (HFE) focuses on improving system design through an examination of competence, team-working, information processing, compliance with procedures and coping with stress and time pressure. In addition, HFE is concerned about prospective system design based on the principles that safety is about control and risk management is about applying appropriate constraints within the system. HFE does not address problems by teaching people to modify their behaviours - rather it addresses problems by modifying the design of the system to better aid people. HFE is not about eliminating ‘human error’. Rather it is about designing systems that are resilient to unanticipated events. HFE work ranges from the individual to the organisational level.

Where to start?

But where is the management of a company supposed to start? This has now been answered by the release of ISO 27500 in March 2016 which is intended for executive board members and policy makers of all types of organisations (whether large or small) in the private, public and non-profit sectors. These are not standards but a series of advisory principles for a human-centred organisation. We continually hear how management value their staff as their main asset and so to meet these criteria organisations should:

• Capitalise on differences between employees and see diversity as a corporate strength.
• Recognise that diversity and performance actually do go together.
• Ensure that usability and accessibility are strategic business objectives.
• Adopt a total systems approach using systems theory.
• Ensure the health, safety and well-being of employees.

Companies and other organisations that are committed to running as “human-centred” should also appoint a person who will champion these principles at board level and develop further internal standards as needed for local organisational requirements.

However, HFE alone is not enough to move from mere compliance to organisational effectiveness. We need to turn to the discipline of safety engineering which concerns identifying hazards in a system and preventing transition to an unsafe state. Safety is a control problem, not a failure problem. Based on years of research about why complex systems fail, Massachusetts Institute of Technology have developed STAMP (Systems Theoretic Accident Model and Process) which is a causality model based on systems theory and thinking.

STAMP it out

STAMP has been adopted by many different safety critical sectors in society across the world. The aim of STAMP is based on the integration of causal factors in the hazard analysis and is divided into two parts: System Theoretic Process Analysis (to prospectively find inadequate control in the system) and Causal Analysis using System Theory (to retrospectively detect inadequate controls that caused non-compliance).

By first defining hazards, control actions and safety constraints can be identified. Then scenarios are identified that lead to violation of safety constraints followed by a causal analysis of unsafe control action. If gaps in the system for managing risk appear, actions can be taken to compensate. This means safety is designed into the system.

A human-centred organisation is more likely to produce a sustainable framework, with clear roles and responsibilities, to generate decision-relevant data which is integrated into regulatory procedures. This is why here in the UK we have set up the world’s first pharmaceutical ergonomics and human factors group.

The aim is to build on what we already know about the evidence underpinning pharmacological and regulatory science with systems theory such as STAMP and HFE. By harnessing human performance, this is truly the path to modernisation and innovation.

[box type="shadow" ]The Three Pillars of HFE

1. Physical HFE examines the topics of human anatomy, anthropometrics, physiology, and biomechanics in relation to the interactions of the user and the equipment used. Practical applications of these considerations include workplace layout, working postures, materials handling, repetitive movements, and work-related musculoskeletal disorder analysis. This is what is commonly associated with ergonomics although the term is now used interchangeably with human factors.

2. Cognitive HFE analyses the cognitive processes that affect the process user and interactions of the user and technology during task completion. These cognitive processes include memory, reasoning, perception, and motor response. Practical applications of cognitive HFE include the assessment of human reliability and human error, human–computer interaction, mental workload, decision-making, skilled performance, work stress, and training.

3. Organisational HFE seeks to account for the complex interactions within socio-technical systems, that is, systems that recognise the interactions between users and technology in the workplace and between society’s complex influences and human behaviour. The pharmaceutical system is one such complex socio-technical system which means it has a high degree of interrelatedness between the social and technical elements in its work and organisation. It examines factors that influence stakeholders work practices – personnel, technology, environment, tasks, and work culture. [/box]

Author: Dr Brian Edwards is Principal Consultant at NDA Regulatory Science Ltd.