This week I’ve been critically reviewing a number of Safety Cases and Process documents which other organisations have written – an exercise we’re often involved with at Safehand. Interestingly, many of the documents I’ve reviewed this week had something in common – they’ve been really rather complicated. After much head-scratching, my mind wandered to the subject of complexity and its relationship with safety.

Complexity is a fascinating topic. The concept arises when a system or process comprises multiple interconnected elements. The elements themselves could take the form of functionality, pieces of hardware, networks, processes, procedures or even people. Further complexity can arise where those elements are subject to change over time.

Safety and complexity have an uneasy relationship. Complex systems often have multiple failure points, are difficult to visualise, can be awkward to maintain and test and can be prone to facilitating human error.

In the domain of Health IT, we frequently see complexity arise in two key areas, the Health IT systems which we subject to safety analysis (design complexity) and the processes we employ to assure those products (process complexity). Design complexity is a fascinating topic, but that’s for a later blog post. This week, it was the sheer complexity in organisations’ safety processes and procedures which caught my eye.

The DCB 0129 and 0160 Standards require us to define and document a Clinical Risk Management Process (or System). Such a process will typically set out the steps followed, personnel involved, techniques applied, tools used, governance methods, etc. Some organisations will choose to keep their process light and agile, whilst keeping an important eye on the level of rigour. Others will opt for a complex system describing the detailed intricacies of workflows and stakeholders. Neither is right or wrong per se – but one or the other could be inappropriate for the organisation into which it is implemented.

Complexity within a process can arise from multiple different factors – the number of steps one is required to follow, the dependencies involved, the level of variability that needs to be accounted for and the number of interactions and relationships between stakeholders. For many large organisations, the seeds are sewn for process complexity to flourish.

But a document describing a complex, intricate process in not necessarily a good process. As humans we have a fundamental need to grasp the methods we are expected to employ. We need to be able to visualise the start, middle and end of activities. There is a danger that our Clinical Risk Management Process could be forensically accurate, yet be impossible to consume for an average practitioner.

Let’s take an example. The implementation of a clinical risk management process necessitates people, indeed a multidisciplinary team of people along with signoff, approval arrangements, etc. One might therefore surmise that a working process will need to describe how that organisation hangs together, the various departments, committees, boards, lines of reporting, etc. What emerges can be a mammoth work of HR brilliance – yet the reader is overwhelmed with detail and is left struggling to determine what is relevant to safety.

Engineers love to talk about the KISS principle – Keep It Simple, Stupid! This is the notion that systems or processes can nearly always be described in simpler terms to aid comprehension, efficiency and maintainability. Where further detail is called for, this can always be communicated in subsequent layers of documentation and SOPs – materials to be consulted at the choice of the reader as required.

Let’s continue our example. What kind of people really need to be involved in your Clinical Risk Management Process?:

  • A representative of Top Management – to own and govern the objectives
  • A Clinical Safety Officer – to execute the process and sign off the documentation
  • A wordsmith – to physically create the DCB 0129/0160 deliverables
  • Supporting personnel – to provide subject matter expertise

That’s it. It’s perfectly possible to take these four functions and attribute them to people in an otherwise complex organisational structure. The method is simple and easy to consume yet results in no lack of rigour or effectiveness.

So when the next time comes to review your Clinical Risk Management Process, ask yourself, could this be simplified? At Safehand one of our primary objectives is to keep things digestible and therefore useful for our customers. Based on the KISS principle, I’m not sure whether that means we’re clever - or stupid.