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Safety management systems: an introduction for healthcare


Those who work in healthcare are aware of the need to protect patients from harm. Despite this, there are ongoing patient safety incidents across healthcare organisations, some of which have been highlighted in previous Healthcare Safety Investigation Branch (HSIB) investigations.

Other industries where safety is critical, such as aerospace, aviation, maritime, rail, oil and gas, defence, and nuclear power, take a structured approach to managing safety through the use of safety management systems (SMSs). This report explores the way SMSs are used in these industries and how the principles of an SMS could contribute to more effective safety management in healthcare.

An SMS is a proactive and integrated approach to managing safety. It sets out the necessary organisational structures and accountabilities and will continuously be improved. It requires safety management to be integrated into an organisation’s day-to-day activities. There is no one-size-fits-all SMS, however, there are four recognised areas associated with many SMS frameworks:

  • safety policy - establishes senior management's commitment to improve safety and outlines responsibilities; defining the way the organisation needs to be structured to meet safety goals
  • safety risk management - which includes the identification of hazards (things that could cause harm) and risks (the likelihood of a hazard causing harm) and the assessment and mitigation of risks
  • safety assurance - which involves the monitoring and measuring of safety performance (e.g., how effectively an organisation is managing risks), the continuous improvement of the SMS, and evaluating the continued effectiveness of implemented risk controls
  • safety promotion - which includes training, communication and other actions to support a positive safety culture within all levels of the workforce.

The purpose of an SMS is to ensure that an industry achieves its business and operational objectives in a safe way and complies with the safety obligations that apply to it. However, it is not just a paper-based or electronic system specifically developed for demonstrating compliance with regulatory frameworks. Instead, an SMS should be a dynamic set of arrangements which grows in maturity and develops as the industry evolves.

HSSIB has made an SMS explainer video to introduce the concepts described in this report.

The investigation

This investigation explored how SMSs are used in other safety-critical industries and the current approaches to managing safety in healthcare.

The investigation interviewed people across a range of safety-orientated roles to understand their approaches to safety management. These safety leaders were from industries including healthcare, aerospace, aviation, maritime, rail, oil and gas, and nuclear power.


The investigation identified three key opportunities for an organised approach to safety management in the healthcare system:

SMS development in healthcare

  • There is an opportunity to improve safety activities in healthcare to increase proactivity and coordination across and within organisations.
  • In other safety-critical industries an SMS is mandated in regulation, but healthcare organisations are not required to have all four areas of an SMS.
  • There is an opportunity to improve standardisation in the coordination of safety activities within and between different organisations across healthcare, in terms of how risks are escalated and managed.
  • An effective safety system and culture requires a shared understanding of safety management principles.
  • There is variability in the current language and definitions that describe the safety activities, functions and processes already common across healthcare.

Safety accountability frameworks across healthcare

  • For effective safety management, clear lines of accountability and responsibility are needed. Within an SMS, everyone has some measure of responsibility, such as reporting unsafe conditions. Accountability takes responsibility to another level. When someone is accountable, they are responsible for systems and processes that assure safety.
  • If there is no co-ordinated approach in place, accountability and responsibility can become misaligned, leading to gaps in the oversight of safety management.
  • While there are clear accountabilities for safety at provider level through the Care Quality Commission regulation, there is no multi-level framework that specifies who should be accountable for the management of safety risks across the healthcare system.
  • There is consensus within other safety-critical industries that effective safety management is only possible when there is a clear accountability framework that underpins the process.

Safety maturity assessments across healthcare

  • The term safety maturity is used to describe how far an organisation has developed and embedded its SMS.
  • Existing maturity frameworks in healthcare do not promote the principles of SMSs, do not define the key components of a healthcare SMS, and do not provide organisations with a road map for incremental development of their safety activities.

Future work

Future work will need to explore the applicability of the SMS approach to healthcare.

This could involve:

  • mapping current safety management activities in healthcare to SMS principles and identifying opportunities for improvement
  • determining if planned and ongoing changes to the way safety is managed in healthcare would be usefully guided by SMS principles
  • further understanding how an accountability framework could support an SMS approach in healthcare
  • understanding how safety issues and risks for inclusion health groups are identified and then managed through an SMS approach.

If improvement opportunities are identified, work would need to establish how SMSs in healthcare could be appropriately and effectively implemented.

Investigation report