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While traditional methods such as Failure Mode and Effects Analysis (FMEA) are well-established, they often reach their limits in clinical practice. This is due in particular to the subjectivity of fault identification. I would like to propose the Hazard and Operability Study (HAZOP) as a complementary risk analysis method. HAZOP offers a structured, systematic approach to risk identification and assessment, particularly suited to analysing process risks and human factors. Unlike FMEA, HAZOP uses guide words (e.g. NO, MORE, LATE, LESS, OTHER THAN) to explicitly identify and analyse potential deviations from tasks and procedures.  A systematic approach to identifying and assessing clinical risks Despite the implementation of risk management systems, practice often falls short of expectations. This is due, among other factors, to the complexity of clinical processes, the dynamics of the work environment, and interprofessional interfaces, which make a holistic risk assessment difficult. Although traditional methods are widely used, they reach their limits in clinical practice: Subjectivity: When using traditional methods such as FMEA, which rely on the team’s spontaneous fault detection and experience, critical risks are easily overlooked as they are not recognised as ‘failure modes’. Monocausality: Traditional failure-mode-based approaches lead to a monocausal derivation of causes and effects. Human factors as ‘operator error’: Human errors are easily classified as ‘user problems’ without questioning the systemic causes (e.g. time pressure, unclear responsibilities, inadequate communication). Against this background, I propose the Hazard and Operability Study (HAZOP) as a complementary risk analysis method. The HAZOP method was originally developed in the aviation industry and has established itself there as the gold standard for analysing risks in highly complex, safety-critical environments. HAZOP enables the approach required by ISO 31000 as a structured, step-by-step approach: Risk identification Risk analysis Risk evaluation Risk identification using guide words The method uses guide words as a heuristic to systematically identify potential process deviations as a starting point for the risk analysis. These guide words are adapted to clinical reality and enable a comprehensive risk analysis: Guide Word: Possible deviation. No: Failure to perform a task. More: Excessive performance of a task. Less: Inconsistent performance of a task. Late: Delayed performance of a task. Other than: Incorrect execution of a task. Using guide words as a starting point for risk identification also helps to involve those with little experience in risk management in the process. A list of guide words can and should be adapted to the specific requirements of the specialist department. Practical application: Example 'documentation of vital signs' Task: Recording and documenting vital signs in the intensive care unit. Guide word: Possible deviation No: Blood pressure is forgotten. Late: Documentation is delayed, delaying further diagnosis. Less: Not all vital signs are measured. Other than: A mix-up of patients in the documentation. Risk analysis The identified risks can be assessed using a two-dimensional risk matrix, like in other risk tools: Probability of occurrence (scale: ‘almost impossible’ to ‘almost certain’). Impact (scale: ‘no health consequences’ to ‘life-threatening consequences’). This commonly used and well-known assessment method enables measures to be prioritised and helps hospitals to proceed in a resource-efficient way. Risk evaluation and identification of measures Preventive and corrective measures are developed during interprofessional workshops, in which representatives from all relevant professional groups (doctors, nursing staff, administration, IT) work together to evaluate risks and propose solutions. Typical measures include: Process optimisations (e.g. standardisation of documentation procedures). Training to raise awareness of human factors. Technical adjustments (e.g. introduction of digital checklists). Clarification of responsibilities (e.g. through clear SOPs). Discussion The HAZOP method offers several key advantages that are particularly relevant to clinical patient safety: The use of guide words enables risks that are often overlooked to be systematically identified. This reduces subjectivity in error detection and enables more objective prioritisation of measures. The method allows for the analysis of human and organisational factors. This enables a holistic view of incident causes and supports hospitals in developing systemic solutions. HAZOP can be seamlessly integrated into the SEIPS 2.0 approach, which enables a coherent risk assessment that accounts for all relevant factors. The approach promotes collaboration among professionals from different disciplines. This strengthens the learning culture and helps to close governance gaps. Thanks to the structured approach and the use of guide words, risk analysis can be carried out more quickly and efficiently. Conclusion The HAZOP method, with its guide words, is a proven, systematic and evidence-based tool for improving clinical patient safety. It enables a comprehensive risk analysis that takes into account technical, procedural and human factors. Do you use the HAZOP method? We would love to hear from you if you're using HAZOP in a clinical setting so we can share real-life examples of its use. Email us at [email protected] or comment below (you need to be signed into the hub; sign up here, it is free and easy to do).

Martin Fletcher, hub topic lead for professionalisation and regulation, has been part of transformational change in professional regulation through his tenure as Chief Executive of the Australian Health Practitioner Regulation Agency (Ahpra). In a new blog for the hub, Martin asks: How do we better connect the work of professional regulation with a systems focus on improving patient safety? And how do we navigate this interface in a health and societal context which is rapidly changing? Zubin Austin writes eloquently about the challenges of the ‘chaotic tumult’ of the many wicked problems that face professional regulators and, indeed, our health system more widely.[1] These form both the context and scaffolding for our work in years to come. The rise of entrepreneurial and profit-driven models of care, telehealth, unregulated medicines for sale online, the role of social media and AI-driven therapeutics are disruptors which have introduced new risk profiles. Traditional regulatory frameworks and approaches to patient safety must adapt. These shifts demand new thinking around safety, accountability, transparency and equity. Traditionally, professional regulation has more narrowly focused on the conduct, competence and performance of individual health practitioners, with an emphasis on public protection. However, we know that the safety of patients is shaped by a wider range of inter-related factors, including clinical governance, team dynamics, design of systems and processes, technology and organisational safety culture. There can be no healthcare without a health workforce. And an ethical, safety-conscious, competent and accountable health workforce is critical for a safe, high quality healthcare system. I have previously written for Patient Safety Learning on the need to more closely link the work of service, product and system regulators, and patient safety improvement bodies. Shared goals, role clarity, information flows and aligned actions are critical. When we operate in silos, we risk missing the bigger picture. Without coordinated action across agencies, patients remain vulnerable. The rapidly growing cosmetic practices sector illustrates these challenges vividly. In both Australia and the UK, reviews have shown that regulating practitioners alone isn’t enough.[2] [3] Products, procedures, facilities, social media, information asymmetry, service licensing arrangements and weak professional ethics all contribute to the potential risk of harm to patients. More widely, there are significant opportunities to better use and share data and intelligence to both anticipate and understand risks of patient harm. The legalisation of medicinal cannabis in Australia powerfully illustrates this need. Incident reports, notifications and complaints are often lag indicators—we need to get ahead of emerging risks of harm to patients, especially in the face of the many healthcare disruptors we face. I hope the hub community is a vehicle for sharing ideas, strategies and real-world examples of how to build foundations and bridges between professional regulation and patient safety improvements more widely. New thinking and approaches are needed. And despite many differences in the way that health systems are organised and funded across the world, there are many common challenges. References Austin Z, Haji A. Regulation of wicked problems: opportunities, responsibilities, and threats. J Med Regulation. 2023;109(3):6–11. doi:10.30770/2572-1852-109.3.6. Brown A, Duggan A, Kirkland A, McCausland R. Independent review of the regulation of medical practitioners who perform cosmetic surgery: Final report. Melbourne: Australian Health Practitioner Regulation Agency; August 2022. UK Parliament. The regulation of non-surgical cosmetic procedures in England. House of Commons Library, 10 September 2025. Further blogs on the hub from Martin Professional regulation and patient safety systems: parallel planets or partners in improvement?

In healthcare a single report—no matter how minor—can challenge an assumption and shift an entire system toward safer care. We often assume that better tools, smarter systems and stronger procedures should naturally lead to safer care. Yet across many healthcare organisations, familiar patterns of preventable harm continue to reappear. This raises an important question: why do these incidents persist—even in environments that invest heavily in quality and safety? Recent national reviews offer a revealing insight. A 2025 U.S. Office of Inspector General report found that hospitals captured less than half of actual patient harm events—meaning a significant portion of risks never even enters the learning system.[1] A 2024 analysis of more than 280,000 safety events reached a similar conclusion, highlighting ongoing gaps driven by underreporting and inconsistencies in how incidents are documented.[2][3] In my experience, these findings reflect a deeper truth: the issue is rarely a lack of systems—it is a lack of signals. When reporting is incomplete, when near misses remain invisible, and when staff underestimate the value of submitting a report, organisations lose the very information needed to learn, adapt and prevent future harm. In healthcare, we often talk about systems, structures and processes. Yet sometimes, the most powerful lessons come from simple ideas. More than twenty years ago, my mentor, Dr Katrin Kleijnhans, shared a metaphor that continues to shape how I understand patient safety culture: the 'ant' and the 'elephant'. In her view, the ant represents a single incident report—the kind of small observation that frontline staff may overlook or dismiss. The elephant, on the other hand, symbolises the healthcare system with all its complexity, pressures and latent risks. She would often remind our teams that even the tiniest ant can move an elephant. One report—no matter how minor it may seem—can challenge assumptions, reveal hidden vulnerabilities and spark meaningful change. And when many ants come together through consistent reporting, they form a 'colony' that creates a force strong enough to shift an entire system toward safer care. Across my work in risk management, I have witnessed this principle repeatedly. A seemingly simple report—a nurse noticing an unusual pattern, a technician raising a concern, a physician describing a near miss—often became the starting point for redesigning workflows, strengthening barriers or preventing harm before it reached a patient. The impact was almost never in the size of the report itself. It was in the organisation’s willingness to listen. Although Dr Katrin Kleijnhans is no longer with us today, the mindset she instilled continues to influence how teams speak up, take ownership of safety and recognise the value of reporting. Her legacy lives on in every improvement driven by someone who chooses to report a concern. As healthcare evolves and technologies advance, one challenge remains deeply human: how do we build cultures where people feel safe—and motivated—to report? The answer begins with reinforcing a simple truth: Small reports reveal big risks. Repeated patterns expose system weaknesses. Reporting is not an administrative task—it is an act of protection. Every voice matters. To all healthcare professionals: your report might be the ant that moves the elephant. Your observation could be the insight that uncovers a hidden risk, prevents harm, or sparks the next improvement that protects patients and colleagues alike. Building a safer healthcare system does not begin with large projects. It begins with a single report—and the courage to submit it. References Office of Inspector General. Hospitals Did Not Capture Half of Patient Harm Events, Limiting Information Needed to Make Care Safer. 2025. Kepner S, Jones R. Patient safety trends in 2023: An analysis of 287,997 serious events and incidents from the nation’s largest event reporting database. Patient Safety 2024; 6(1): Hoops K, Pittman E, Stockwell DC. Disparities in Patient Safety Voluntary Event Reporting: A Scoping Review - Joint Commission. Journal on Quality and Patient Safety 2024; 50(1):46-48.

Stefan Peil summarises a pilot study he has done to see whether a structured systems model can support the preparation of a morbidity and mortality (M&M) conference discussion. The example used is a coronary angiography risk scenario to explore whether a model-based representation of patient safety knowledge could serve as a reliable basis for an artificial intelligence (AI)-assisted decision template. The work was produced to address a practical problem in patient safety: relevant information for M&M preparation is often spread across diagrams, reports and team knowledge, which can slow and make shared understanding less consistent. The pilot study, therefore, examined whether systems modelling could help organise, make transparent and reuse safety relevant information in a more structured way. The full study is attached at the end of this page. The challenge The identified challenge was the lack of a structured, reusable approach to preparing patient safety discussions for M&M conferences. The aim was not to automate clinical judgement, but to test whether a model-based risk analysis derived from team knowledge could serve as a structured input for drafting an M&M decision template. M&M preparation often relies on fragmented information and informal interpretation. In complex clinical environments, such as coronary angiography, risks do not arise from a single isolated factor. They emerge from the interaction between tasks, people, technology, information flow and organisational conditions. In this specific pilot example, the safety concern was a risk scenario in coronary angiography in which cognitive overload during real-time decision-making and escalation could contribute to complications not being detected in time. This formed the basis for testing whether a structured model could provide a clearer and more traceable starting point for discussion. Method and measures To explore this, a systems model based on Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 was created in Systems Modeling Language (SysML) using SPARX Enterprise Architect. The objective was to represent the work system, the contributory task factor, the resulting risk and the proposed measures in a traceable form. The model focused on one coronary angiography scenario. The critical task factor was described as cognitive density in real-time decision-making and potential escalation. In the model, this contributed to the risk that complications would not be detected in time. The text states an impact on quality of care, an occurrence rating described as relevant and an overall risk class of moderate. The proposed measures were: pre-procedure briefing risk-adapted staffing standardised laboratory layout regular simulation drills. The intended achievement was a more structured, transparent and reusable basis for M&M preparation and discussion. Outcomes and lessons learned The pilot showed that a structured model can be a useful way to organise safety-relevant knowledge. Because the model linked work system elements, risks and measures in a traceable way, it provided a clearer starting point for discussion than unstructured text alone. The practical process tested in this pilot was: defining a relevant patient safety scenario in coronary angiography modelling the work system and the contributory task factor linking this to a patient safety risk documenting possible mitigating measures using the model as the basis for an AI-assisted one-page decision template. One important observation was that the AI-generated output reflected the underlying model's content. This suggests that a structured model can support more consistent synthesis than relying only on memory or informal interpretation. The text does not describe multiple alternative technical approaches in detail, so it cannot be stated from the source whether other options were formally compared or ruled out. It also does not state direct patient involvement. Staff involvement is referenced indirectly by using team knowledge as an input to the model. The text does not report formal measurement tools, outcome metrics, time savings, patient safety indicators or model costs. Therefore, no validated impact measurement can be claimed from the source. A key lesson learnt was that AI can assist with drafting and synthesis, but cannot replace clinical judgement, governance or safety review. Any output generated from the model still needs to be checked against the source material and reviewed by responsible clinical and patient safety leads. Impact This work is only a prototype, not as a formal effectiveness study. As a result, the impact that can be claimed is limited. The main result was that the structured model appeared to support: clearer organisation of safety-relevant knowledge better traceability between work system factors, risks and proposed measures a more consistent starting point for multidisciplinary discussion reuse of modelled information for drafting a one-page M&M decision template. At the same time, the the study is explicit about what was not demonstrated. The pilot did not test whether the approach: improved patient outcomes reduced harm shortened preparation time in routine practice improved care delivery in a measurable way. A further limitation was that only a single, limited example was used, and some information was withheld for data protection reasons. This means the results were narrower than would be needed for broader implementation decisions. What worked was the structured linkage between the work system, contributory factors, risks and measures. What remains uncertain is whether this translates into measurable operational benefit in routine clinical governance. A likely barrier to improvement is the need for continued expert review, because AI-generated output cannot be used without clinical validation and governance oversight. If repeated, the next stage would need a clearer evaluation design, including defined measures of clarity, consistency, usability and possibly preparation time. Next steps The next step is a practical pilot in real clinical governance settings. A suitable next-stage comparison would be conventional M&M preparation versus model-supported preparation in a small, clearly defined pilot. The proposed questions for the next phase are: Does the approach improve clarity and shared understanding? Does it help teams identify contributory factors more systematically? Does it support consistency and traceability of measures related to patient safety? The study does not provide evidence of long-term organisational change, staff reaction, patient impact statistics or system-wide implementation results. Therefore, those elements cannot yet be stated as outcomes. However, based on insights from the pilot study, the anticipated longer-term value would be to make patient safety knowledge: more structured more reusable easier to discuss across professional groups more clearly linked to the wider work system rather than to isolated errors. A sensible next step would, therefore, be a controlled local test with defined governance, clinical review and evaluation criteria before any broader adoption.

This month, the Professional Standards Authority have published their updated and combined Standards for the organisations they oversee and accredit. They are the result of extensive engagement, consultation and careful reflection. The Standards have been revised with one clear aim in mind—strengthening patient safety and public protection through robust professional regulation and registration. In this blog, Amanda Partington-Todd, Interim Director of Regulation and Accreditation, explains why the new Standards are good for patient safety.  Clearer expectations mean safer practice If our expectations of the professional regulators and Accredited Registers are unclear, it becomes harder to deliver them well. One of the most important changes we have made is to improve the clarity of our requirements by refining and streamlining the Standards. Clear standards support better decision making. They reduce ambiguity. And they help organisations focus on what really matters—protecting patients and the public, and maintaining public confidence in the health and care professions. The same safety bar for everyone We now have one single set of Standards for both professional health and care regulators and Accredited Registers. This is important. Different organisations operate in different ways. But when it comes to patient safety, the public should expect the same high standards, regardless of the type of body involved. By aligning our expectations, we are making it clear that the level of protection afforded to the public should not differ, even if regulators have legal powers that Accredited Registers do not. Strong governance and leadership protect patients Research and experience show that organisational culture and patient safety are closely linked. That is why the new Standards place consistent expectations on governance and leadership. Senior leaders must have appropriate oversight of how their organisations are run. They must understand the risks. And they must be accountable for how concerns are handled. Good governance helps create a culture where issues are identified early, concerns are taken seriously, and learning is embedded. That culture directly supports safer care. A stronger focus on risk and safeguarding Regulation exists to reduce the risk of harm. Our revised Standards strengthen expectations around evidence and risk-based decision-making, particularly in relation to professional suitability. This includes clearer expectations around safeguarding and appropriate checks, such as criminal records checks, where relevant. Safeguarding is not a technical requirement—it is fundamental to public safety. By reinforcing proportionate, risk-based approaches, the new Standards strengthen our expectations of how regulators and Accredited Registers assess professional suitability throughout a practitioner’s career, holding them to account for maintaining effective safeguards to protect the public. Better collaboration means fewer missed risks Patient safety can be undermined when information is not shared or when concerns are not addressed early. The new Standards encourage stronger collaboration and alignment across regulatory partners. By working together, sharing relevant information and reducing gaps between organisations, we can reduce the risk of missed opportunities to act. We also want to see concerns resolved as early and as locally as possible, where appropriate. Early action taken locally can prevent problems escalating; for example, by removing barriers to people raising complaints, and improve outcomes for patients and the public. Raising the bar from the very start For organisations applying to join our Accredited Registers programme, we have strengthened the tests we apply at the earliest stage. Improved eligibility requirements and clearer public interest assessments mean we can make the right decisions about which organisations are suitable for accreditation before they enter the programme. This early scrutiny strengthens public protection and supports confidence in the quality of Accredited Registers. Focused on impact, not just process Across all of these changes, one principle runs through the new Standards—regulation must make a real difference. It is not enough to have policies in place. The systems must work. Risks must be identified. Concerns must be handled fairly and effectively. Organisations must be willing to learn and improve. By clarifying expectations, aligning standards, strengthening governance, reinforcing safeguarding and encouraging collaboration, we have built a framework that is sharper, more consistent and more focused on outcomes. Patient safety depends on strong, effective regulation and registration. Our updated Standards are designed to achieve exactly that by driving continuous improvement and vigilance from the regulators and Accredited Registers. This ensures that regulation continues to protect the public and maintain confidence in health and care professions.

The pharmaceutical industry plays a vital role in protecting human life and health. Medicines, vaccines and healthcare products directly impact millions of people around the world. Because of this, pharmaceutical companies must operate ethically and responsibly and social due diligence is becoming increasingly important. Social due diligence helps pharmaceutical companies identify, assess and manage social risks related to people, communities and ethical practices. It ensures that business operations respect human rights, employee welfare, patient safety and community well-being. Understanding social due diligence Social due diligence is a structured process used to evaluate how a company’s activities affect people. It focuses on social risks such as unsafe working conditions, unfair labour practices, community health impacts, and ethical issues in clinical trials and supply chains. In the pharmaceutical industry, where trust is critical, social due diligence is essential to maintain transparency, compliance and long-term sustainability. Why social due diligence is critical in the pharmaceutical industry 1. Protecting human rights and worker safety Pharmaceutical manufacturing involves chemical handling, laboratory work and high-risk processes. Social due diligence ensures: Safe working conditions. Fair wages and working hours. Protection from workplace hazards. This helps prevent accidents and promotes employee well-being. 2. Ethical clinical trials and ersearch Clinical trials involve human participants. Social due diligence ensures: Informed consent is properly taken. Participants are treated ethically. Vulnerable groups are protected. Ethical research practices build public trust and meet international standards. 3. Responsible supply chain management Pharmaceutical companies rely on global suppliers for raw materials and active ingredients. Social due diligence helps identify risks such as: Child or forced labour. Poor working conditions. Human rights violations. Monitoring suppliers ensures ethical sourcing and compliance. 4. Community health and social impact Manufacturing plants and research facilities affect nearby communities. Social due diligence evaluates: Community health risks. Access to healthcare. Social disruptions caused by operations. This helps companies reduce negative impacts and support local development. Key elements of social due diligence in pharmaceutical companies Employee welfare assessment This includes reviewing labour policies, safety standards, training programmes and grievance mechanisms to ensure employees are treated fairly and respectfully. Stakeholder engagement Engaging with employees, patients, regulators and local communities helps identify concerns early and improves decision-making. Risk identification and mitigation Social risks can be identified through audits, assessments and surveys. Companies can then create action plans to reduce or eliminate these risks. Compliance with regulations and standards Social due diligence ensures compliance with: National labour laws. International human rights standards. Industry-specific guidelines. Benefits of social due diligence for pharmaceutical companies Builds trust with patients and regulators. Reduces legal and reputational risks. Improves employee morale and productivity. Supports sustainable and ethical growth. Enhances brand credibility in global markets. Companies that invest in social due diligence are better prepared to face regulatory challenges and social expectations. Conclusion Social due diligence in the pharmaceutical industry is not just a regulatory requirement—it is a moral responsibility. By focusing on people, ethics and transparency, pharmaceutical companies can ensure safe operations, protect human rights and contribute positively to society. In an industry where human lives are at stake, responsible practices create long-term value and sustainable success. Social due diligence helps pharmaceutical companies move forward with integrity, accountability and trust.

The RiskReimagined 2026 Conference is a premier event for sharing best practice and innovation, designed to help NHS professionals move from awareness to applied implementation. Delegates will gain hands-on frameworks, tested delivery models, and peer-derived insights on embedding safe, equitable, and sustainable transformation within their organisations. Dedicated Skill Clinics provide practical tools, checklists, and implementation templates for enhancing governance, risk oversight, and incident response. Lessons Learned Sessions offer candid reflections from NHS leaders on real-world challenges, course corrections, and successes. This is not a showcase of what to achieve, but a skills exchange on how to achieve it, translating national ambition into measurable improvement. This year’s event is structured around clear outcomes. Delegates will leave understanding: Evolving governance for safer care: clarifying responsibilities for safety oversight at system level and strengthening board leadership, accountability, and assurance around quality and risk. Applying AI and early warning systems: improving early identification of emerging risks and embedding proactive approaches to risk management into everyday clinical practice. Building a learning culture from incidents: encouraging open reporting, meaningful follow-up, and consistent learning from incidents, including effective use of PSIRF, HSSIB insights, and safer medicines management. Strengthening the Estate infrastructure: addressing weaknesses in estates, equipment, and organisational preparedness, while strengthening plans to maintain care during disruption. Improving continuity and trust in patient information: supporting joined-up care through better stewardship, sharing, and governance of patient records, enabling a single, trusted view of the patient journey. Building workforce risk capability: through targeted training, multidisciplinary governance structures, and safety leadership aligned with People and Quality frameworks. Why attend: Earn 8 CPD Points by attending. Build professional confidence through applied, hands-on learning. Access ready-to-use frameworks for governance, interoperability, and workforce transformation. Hear real experiences from peers and leaders driving NHS improvement. Leave with practical artefacts, toolkits, and action plans for local rollout. Join a community of NHS professionals committed to capability-building and sustainable delivery. Who would benefit: This conference is ideal for Board Members, Chief Executives, Governance and Quality Leads, Patient Safety Managers, Risk and Assurance Directors, and ICS Executives driving NHS transformation. It will also benefit clinical and operational leaders, CCIOs, CIOs, service managers, and workforce planners seeking practical guidance on embedding safety, accountability, and resilience. Suppliers, digital partners, and academic collaborators will gain insight into implementation priorities, workforce skill gaps, and the real-world enablers shaping the next decade of NHS transformation. Register