What is human factors in healthcare?

Human factors in healthcare is the application of evidence about human behaviour, capability and limitation to the design of care, systems, environments, teams and technology so that care becomes safer and more effective.

How does human factors improve patient safety?

Human factors improves patient safety by identifying how system conditions shape performance. It helps organisations improve communication, decision-making, procedures, usability, workload, teamwork and culture so that risks are reduced and learning is stronger.

What is the link between human factors and PSIRF?

PSIRF is designed to support systems-based learning from patient safety incidents. Human factors provides the methods and perspective needed to understand how people interact with systems, which makes it highly relevant to investigation, learning and improvement under PSIRF.

Why did PSIRF replace the Serious Incident Framework?

PSIRF replaced the Serious Incident Framework because the NHS wanted a more proportionate, flexible and system-focused way of responding to incidents, with more emphasis on compassionate engagement, learning and improvement rather than a narrow threshold-based process.

Can human factors support incident investigation in healthcare?

Yes. Human factors can strengthen incident investigation by helping teams look beyond individual actions to understand the wider system influences on care, decision-making and outcomes.

Do you support healthcare organisations with PSIRF services in the UK?

Yes. Promethean HD can support healthcare organisations with human factors input to PSIRF implementation, systems-based investigation, learning responses, safety culture and service improvement.

Absence of Evidence is Not Evidence of Absence: Weak Signals, Patient Safety and Governance

Steve Franklin

Jul 28

6 min read

This has to be one of my most-used phrases when working with teams, especially leadership teams. It matters because a lack of reporting can be misleading. If nothing is being raised, it does not automatically follow that everything is safe, effective or well understood. It may mean that people have stopped speaking up, the right signals are not being collected, or leaders are looking in the wrong places. It can translate in a few ways:

1) The Safety I mindset of if there is nothing ‘going wrong’ being reported, then surely everything must be good.

2) Silencing the voice of the user and worker. If staff and users are not making a fuss, then everything is good.

Let’s dig into these.

With the first one, what do we often see? Metrics focused on negative outcome events, such as harm, actual impact, lost time frequency rates or RIDDOR numbers. Metrics that focus on how things look, such as categories by incident type, medication errors, slips, trips or falls. What can then disappear is the near miss, the good catch and the hazard observation. That matters because it leaves the organisation looking at risk through a very reactive lens.

With the second one, we start to experience erosion in culture. If staff and service users’ voices are not heard, they become quieter. Little problems remain, workarounds are locally implemented to keep the show on the road, and the organisation drifts into failure.

The space shuttle disasters of Challenger and Columbia are powerful reminders of why this matters. In both cases, the warning signs were not simply absent. They were present, partial, normalised, disputed or not given enough weight in the rooms where decisions were made.

During the Challenger investigation, the Rogers Commission identified serious weaknesses in how safety concerns were surfaced, analysed and included in decision-making. Its chapter “The Silent Safety Program” highlighted weak problem reporting requirements, inadequate trend analysis and the absence of safety voices from critical launch discussions. The lesson is not that nobody knew anything. It is that the organisation did not have a strong enough system for turning weak signals into meaningful challenge.

Columbia tells a similar story in a different form. Foam strikes had happened before and were increasingly treated as an accepted part of shuttle operations. Familiarity mattered. When something abnormal happens often enough without catastrophe, organisations can start to treat it as normal. The absence of disaster becomes wrongly interpreted as evidence that the risk is controlled.

Sometimes signals are missed not because people are careless, but because they have become used to seeing them. When the same people, with the same professional background, assumptions, pressures and organisational history, review the same risks repeatedly, the abnormal can start to feel normal. That is one of the human factors lessons I take from both Challenger and Columbia.

The Rogers Commission noted that no safety representative, reliability engineer or quality assurance engineer was invited to the critical January 27 teleconference between Marshall and Morton Thiokol. It also noted that there was no safety representative on the Mission Management Team making key countdown decisions. That is a powerful governance lesson: the voices in the room shape the questions that get asked.

The issue was not simply that “nobody knew anything.” It was that the system did not create enough challenge, diversity of thought or independent safety voice to properly test what people thought they knew. This matters in every sector, and isn’t just a ‘safety’ thing. As you know, we predominantly work with healthcare organisations, and over the past 3 years, we have seen a significant shift in how that industry operates in the UK. Those changes aren’t even over yet. How commissions are commissioned, which services are commissioned and how those services are delivered will continue to evolve, and very likely at quite some pace. Ensuring that decisions are thought through, stress tested and identify key risks prior to the change will be critical for the safe ‘landing’ of those services.

If a leadership team only hears from people who are used to the current way of working, it may miss the workaround that has become routine. If assurance only comes through formal reports, it may miss the informal concern that everyone locally knows about. If performance meetings only review harm events, they may miss the near misses, good catches and weak signals that show where risk is building. If senior teams only speak to other senior teams, they may miss what frontline staff, patients, service users, families or junior colleagues can already see. This is why diversity of perspective is not a “nice to have”. It is a safety, quality and governance issue.

I don’t just mean demographic diversity, although that matters. I also mean cognitive, professional, experiential and positional diversity.

· Who sees the work as imagined?

· Who sees the work as actually done?

· Who understands the policy?

· Who understands the workaround?

· Who has the authority?

· Who has the lived experience?

· Who is close enough to the issue to see the weak signals?

· Who is distant enough from the issue to ask the obvious question that everyone else has stopped asking?

Good decision-making needs all of those perspectives.

So how do teams avoid becoming trapped in their own assumptions?

A few practical methods I like:

1) Pre-mortems

A pre-mortem asks a team to imagine that a project, pathway change or improvement programme has failed badly, and then work backwards. What happened? What was missed? Who was not heard? Which assumptions went untested?

It creates permission to name risks before implementation, rather than explaining them after failure. The value is not just better risk identification. It is making constructive challenge normal.

2) Shadow boards

A shadow board or shadow leadership group brings in people who are not usually in the executive room: junior colleagues, frontline staff, emerging leaders, different professional groups, or people closer to service users and operational reality. Its role is not to duplicate the formal board. It is to test assumptions, bring weak signals, challenge language and ask whether the formal picture matches how the work really feels on the ground.

3) Red teams or challenge panels

Red teams or challenge panels give a group explicit permission to challenge the plan. Their role is not to be difficult. It is to ask better questions. What are we assuming? What would make this unsafe? What are we not measuring? Where could this fail without being noticed early enough? Who has not been consulted? What would the frontline, service user or family notice first?

The point is to separate challenge from personality. It becomes a role, not an act of disloyalty.

This is particularly relevant now. Many healthcare organisations are either reviewing, or are about to review, their Patient Safety Incident Response Framework (PSIRF) plans. That should not be a paper exercise. PSIRF was intended to support a shift towards learning, improvement, proportionate response and better engagement with those affected by patient safety incidents. If the review only asks whether the plan exists, it misses the point. The better question is whether the plan is helping the organisation understand where risk is building, where learning is not turning into improvement, and where the current governance model is creating assurance rather than insight.

This is where these activities can add real value. Pre-mortems, shadow boards, challenge panels and structured reviews of evidence can help organisations develop PSIRF plans that are more robust, more targeted and more likely to make an impact in the areas that matter. They help move the conversation away from “what incidents did we have?” and towards “what are our systems trying to tell us, who have we not heard from, and what needs to change?”

At Promethean Human Designs, we support organisations with exactly this kind of governance review. That can include PSIRF plan reviews, clinical governance reviews, corporate governance reviews, and broader board effectiveness evaluations. The focus is the same: helping boards and leadership teams test whether their arrangements are giving them meaningful assurance, whether the right voices are being heard, and whether governance is driving real change rather than simply producing more documentation.

These are not theoretical exercises. Used well, they help leaders deliberately surface weak signals before those signals become harm, failure or reputational damage. The skill is in designing the process, creating the right conditions for honesty, and turning what people share into action rather than another report that sits on a shelf.

The Challenger and Columbia lesson is not simply “listen to engineers”, although that matters. It is broader than that. It is about designing governance systems where different forms of knowledge are present, respected and acted on.

· Technical knowledge.

· Safety knowledge.

· Frontline knowledge.

· User knowledge.

· Lived experience.

· Independent challenge.

· Fresh eyes.

When a team lacks diversity of perspective, it can become very good at answering the wrong questions. And when a risk has been normalised, the most important voice in the room may be the one that asks:

“Why are we accepting this?”

Absence of evidence is not evidence of absence. Sometimes it is evidence that the right people were not in the room, the right questions were not being asked, or the organisation had become too used to seeing the warning signs.

If your organisation is reviewing its PSIRF plan, clinical governance arrangements or board assurance framework, Promethean Human Designs can help you test whether your current approach is surfacing weak signals, hearing the right voices and turning learning into improvement.