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Navigating Hazards: Importance of Safety Cases in the Oil & Gas Industry

Safety is a paramount concern within the oil and gas industry. With complex operations, high-risk activities, and the potential for catastrophic incidents, it is crucial to prioritise and ensure the well-being of workers, the environment, and surrounding communities. In this industry, safety cases play a vital role in mitigating risks and providing a framework for navigating hazards effectively. This article explains what is a safety case and safety case examples.

Table of Contents

Importance of Safety in the Oil & Gas Industry

Safety is not just a priority but an absolute necessity in the oil and gas industry. Workers in this sector face various hazards daily, including but not limited to:

• Exploration and production risks: From drilling and excavating operations to offshore platforms and pipelines, the oil and gas industry involves intricate processes that can expose workers to numerous dangers. These risks include equipment failures, fires, explosions, and natural disasters like hurricanes and earthquakes.
• Transportation hazards: Transporting oil and gas products via pipelines, ships, tankers, or trucks comes with risks. Accidents, leaks, spills, and explosions can occur during transportation, posing severe threats to human life and the environment.
• Chemical exposures: Chemicals and substances used in the exploration, extraction, processing, and refining of oil and gas can be hazardous if not handled properly. Workers may encounter toxic gases, flammable substances, corrosive chemicals, and other harmful materials that can have long-term health effects.

Given the gravity of these hazards, companies within the oil and gas industry must establish robust safety measures and systems to protect their workforce and minimise the occurrence of incidents.

Overview of Hazards Faced in the Industry

Navigating oil and gas industry hazards requires a thorough understanding of the risks involved. Some of the key hazards include:

• Fires and explosions: The presence of flammable materials and ignition sources can lead to catastrophic fires and explosions. These incidents often result from inadequate maintenance, poor equipment integrity, or human errors.
• Gas leaks: Gas leaks, such as methane, pose a substantial risk due to their flammability and potential for asphyxiation. These leaks can occur during drilling, transportation, or storage processes, leading to significant safety and environmental concerns.
• Worksite accidents: Oil and gas operations involve heavy machinery, high-pressure systems, and rigorous physical labour, making worksite accidents a significant hazard. Falls, equipment malfunctions, and accidents related to transportation and lifting operations are common in this industry.
• Hazardous substances and chemicals: The handling, transportation, and storage of hazardous substances and chemicals pose a wide range of risks. Exposure to toxic substances, improper storage, and mishandling can result in severe health effects and environmental contamination.

Safety cases play an essential role in effectively addressing these hazards, demonstrating a company’s commitment and ability to manage risks and protect personnel, assets, the environment, and the public.

The next section will delve deeper into safety cases and understand their significance in the oil and gas industry.

What is a Safety Case?

Definition and purpose of safety cases.

A safety case is a comprehensive document that outlines the management of risks and safety measures within the industry.

One definition is that safety Cases are structured arguments supported by evidence that prove a system is acceptable and safe for a specific application under a specific operating environment.

It is a fundamental tool for demonstrating how hazards are identified , assessed, and controlled to ensure a safe working environment. Safety cases provide an evidence-based approach to managing risks and establishing a strong organisational safety culture.

The primary purpose of a safety case is to:

• Identify and assess hazards: Safety cases require organisations to systematically identify and assess potential hazards and risks associated with their operations. This process involves considering all aspects, from equipment and processes to environmental factors and human activities.
• Control and manage risks: Safety cases define the necessary control measures, procedures, and protocols to mitigate identified risks. These measures encompass engineering controls, safety systems, emergency response plans, and personnel training to prevent or minimise the impact of accidents and incidents.
• Demonstrate regulatory compliance: Safety cases serve as a means to demonstrate compliance with relevant industry regulations and standards. By providing evidence of effective risk management, companies can show that they have taken the necessary steps to operate safely and responsibly.
• Enhance stakeholder confidence: Safety cases communicate a company’s commitment to safety and reputation. They can increase stakeholders’ confidence, including employees, investors, customers, regulatory authorities, and the wider community.

Key Components and Elements of a Safety Case

A well-developed safety case typically includes the following key components and elements:

• Executive Summary: A safety case overview highlighting key findings and recommendations.
• Corporate Safety Policy: A clear and concise statement that outlines the organisation’s commitment to safety and its overall goals and objectives.
• Hazard Identification: A systematic process of identifying potential hazards and risks associated with operations onshore and offshore. This includes analysing equipment, processes, and people’s activities.
• Risk Assessment: A thorough evaluation of identified hazards, including the likelihood and consequences of potential incidents. This assessment serves as the basis for determining the appropriate control measures.
• Risk Management and Control Measures: To minimise or eliminate risks, implement control measures. These may include engineering controls, administrative controls, personal protective equipment (PPE), and emergency response plans.
• Safety Management Systems: An overview of the organisation’s safety management system, including safety policies, procedures, training programs, audits, and monitoring processes.
• Emergency Preparedness and Response: Detailed plans and procedures to effectively respond to emergencies, including evacuation plans, communication protocols, and coordination with external emergency services.
• Performance Monitoring and Review: Methods to monitor and assess the effectiveness of control measures and safety performance. This includes regular audits, incident investigations, and tracking safety-related data.
• Continuous Improvement: A commitment to continuous improvement by learning from incidents, near-misses, and industry best practices. This element ensures that safety practices are updated and refined over time.

By incorporating these components and elements into a safety case, organisations in the oil and gas industry can establish a strong foundation for effective risk management and ensure the safety and well-being of their workers and the environment.

Navigating Hazards in the Oil & Gas Industry

Common hazards in oil & gas operations.

The oil and gas industry operates under complex and high-risk conditions, which expose workers to various hazards. Some of the most common hazards include:

• Fires and explosions: Flammable liquids and gases commonly found in oil and gas operations pose a significant fire and explosion risk. Causes include equipment failure, poor maintenance, and human error.
• Natural disasters: Hurricane wind and torrential rains can interrupt oil and gas operations and cause extensive damage. These natural disasters can also cause spills, fires, and explosions.
• Workers’ safety: Workers in the oil and gas industry face risks of injury from handling heavy and dangerous equipment, working at heights, and exposure to chemicals.
• Human-made incidents: Sabotage, cyber-attacks, and terrorism are major hazards that could cause significant harm to oil and gas infrastructures.

The Need for Safety Cases in Mitigating Hazards

In such a hazardous industry, it is vital to have a proactive approach towards mitigating risks to ensure the safety of workers, assets, and the environment. A safety case provides a vital tool to achieve these objectives through:

• Preventing incidents: By analysing potential risks, identifying obstacles, and implementing protocols and measures to prevent them, safety cases help prevent incidents.
• Reducing consequences of an incident: In case of an incident, safety cases help in quickly identifying the risks and setting up strategies to minimise the consequences.
• Demonstrating compliance: Safety cases help to ensure regulatory compliance while assuring the oil corporation stakeholders of their commitment to safety.

Examples of Real-life Incidents and the Role of Safety Cases in Preventing Them

The oil and gas industry has experienced devastating process incidents that resulted in loss of life, environmental damage, and loss of business. Some of these incidents include:

• Deepwater Horizon Oil Spill: One of the most significant disasters that led to the oil flow from the Macondo Well in the Gulf of Mexico. The explosion and sinking of the rig led to 11 workers losing their lives while extensive damage to marine life and the ecosystem was caused. The incident highlighted the need for effective safety cases to ensure the safety of workers and the environment and the implementation of adequate safety systems.
• Piper Alpha Incident: The oil production platform, Piper Alpha, experienced a fire that eventually led to the destruction of the platform and the deaths of 167 workers. The incident showed that safety cases are critical for preventing such events and ensuring effective emergency response plans.
• Buncefield Disaster : An explosion occurred at an oil storage facility in Hertfordshire, England, leading to the loss of lives and significant damage to homes in the surrounding area and causing substantial firefighting efforts. Safety cases were implemented to reduce the likelihood of the reoccurrence of such incidents through installing safety equipment and frequent inspections.

Safety Case Regulations and Standards in the Oil & Gas Industry

Safety cases are prioritised in the oil and gas industry, as relevant regulations and standards require them. These include:

• ISO 9001: ISO 9001 establishes the quality management systems of a company to ensure the quality of products and services and compliance with legal regulations and standards.
• Occupational Safety and Health Administration (OSHA): OSHA enforces standards for safety and health in the working environment, and oil and gas companies must comply with these standards.
• Regulation of Offshore Oil and Gas Operations : The United States Department of the Interior Bureau of Safety and Environmental Enforcement (BSEE) has regulations that require offshore oil and gas companies to establish and maintain safety cases.
• The Safety Case Regulations 2015 (SCR 2015): This legal regulation was developed in the UK, requiring operators to prepare, maintain and revise safety cases for their activities in the upstream oil and gas sector.

By complying with such regulations, oil corporations can assure regulatory authorities and stakeholders of their commitment to safety, including their willingness to follow best industry safety practices to mitigate risks.

This is to note that safety case regulations may vary by country and region, and it is important to refer to specific regulatory authorities and industry guidelines for comprehensive information and compliance.

Benefits of Safety Cases

Safety cases benefit the oil and gas industry, enabling companies to enhance safety culture, improve risk management, demonstrate regulatory compliance, and build stakeholder confidence. Some of the key benefits are:

1. Enhancing Safety Culture and Awareness

Safety cases play a vital role in creating a strong safety culture within an organisation. By developing and implementing safety cases , companies prioritise safety as a core value, fostering a work environment that values the well-being of its employees. Safety cases promote:

• Improved safety awareness among employees
• Increased accountability for safety-related responsibilities
• Encouragement of safe work practices
• Empowerment of employees to identify and report hazards
• Promotion of open communication and consultation regarding safety concerns

2. Improved Risk Management and Hazard Identification

Safety cases provide a structured framework for identifying and managing risks in the oil and gas industry. With safety cases, companies can:

• Systematically identify and assess potential hazards and risks
• Implement effective control measures and risk mitigation strategies
• Continuously monitor and review safety performance
• Ensure regular inspections and maintenance of equipment and facilities
• Conduct thorough incident investigations and analyses for continuous improvement

3. Demonstrating Regulatory Compliance and Due Diligence

One of the key benefits of safety cases is their ability to demonstrate regulatory compliance and due diligence. Safety cases ensure that companies meet legal and industry-specific requirements, such as:

• Complying with regulations and standards set by regulatory bodies such as OSHA and BSEE
• Demonstrating a commitment to safety and environmental protection
• Establishing and maintaining proper safety management systems
• Conducting regular audits and inspections to ensure ongoing compliance
• Providing evidence of proactive measures taken to minimise risks and prevent incidents

4. Enhancing Stakeholder Confidence and Reputation

Safety cases are instrumental in building stakeholder confidence and maintaining a good reputation for oil and gas companies. Safety cases help companies:

• Assure stakeholders, including investors, employees, and the public, of their commitment to safety
• Provide transparency regarding safety protocols and risk management strategies
• Enhance reputation as a responsible and reliable industry player
• Establish credibility through independent assessments and audits
• Strengthen relationships with regulatory authorities, local communities, and industry partners

Building Successful Safety Cases with SynergenOG: Electronic Safety Case Software and Process Safety Consultancy  Services

SynergenOG provides comprehensive solutions for developing successful safety cases in process industries. With expertise and dedication in the oil and gas industry, SOG can assist you in creating robust safety cases by leveraging experience in the process industry and utilising our safety case software .

By using our safety case software, companies can streamline their safety case development and management process, improving efficiency, accuracy, and compliance. This software can help in improving safety case roll-out.

Learn  More About SOG Safety Case Software

Overall, safety cases are essential tools that help oil and gas companies create a robust safety culture, effectively manage risks, comply with regulations, and build trust with stakeholders, thereby ensuring the well-being of workers, protecting the environment, and securing the industry’s long-term viability.

FAQ -What are Safety Cases

The development of a safety case involves the effective identification, evaluation and control of potential hazards, as well as a positive argument to justify the various choices that have been made to provide for the facility’s safety.

A key consideration of the safety case system is the “ALARP” concept, which requires employers to reduce the risk of hazards to As Low As Reasonably Practicable. “Reasonably practicable” roughly means ‘reasonably possible without undue disproportionate economic cost for the minimal benefit to safety.”

A safety case is a written demonstration of evidence and due diligence provided by a corporation to demonstrate that it has the ability to operate a facility safely and can effectively control hazards.

A key consideration of the safety case system is the “ALARP” concept, which requires employers to reduce the risk of hazards to As Low As Reasonably Practicable. “Reasonably practicable” roughly means ‘reasonably possible without undue disproportionate economic cost for the minimal benefit to safety.’

A safety case will help to drive the applicant to meet its public safety objectives and provide for accountability in doing so. All stakeholders (including the regulator) need to have confidence that applicants have carefully thought through and tested how they will keep the public safe. An effective safety case will give confidence to all parties that the applicant is committed to having an operation that carefully considers and manages the risks to public safety, and that they have the capability and capacity to do so.

Organisations that operate facilities with major hazards that could cause catastrophic damage to health, safety, and the environment are commonly required to submit a safety case.

A Safety Case Advisor is responsible for supporting the Safety Case Manager in developing, maintaining and reviewing the Safety Case for their area.

Operational safety case is a document that consist the information for an installation to demonstrate that there are effective means for ensuring a safe operation throughout facility life. In addition, safety case ensures a comprehensive hazard management process implemented to demonstrate risk has been reduced to As Low As Reasonably Practical (ALARP).

A safety case is a document which provides a clear and comprehensive argument , supported by evidence to demonstrate that a system is acceptably safe to operate in a particular environment.

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The importance of workplace safety: Case study, Norwich V Ipswich security guard

Workplace safety is a critical aspect of any organisation, ensuring the well-being and protection of employees in their professional environment.

Unfortunately, not all employers prioritise safety measures, which can lead to devastating consequences for their workers.

We recently settled a case that highlights the significance of taking workplace safety seriously. The incident involved a female security guard who suffered severe injuries during a football match due to inadequate safety protocols.

Workplace safety – security guard

Our client, a female security guard, found herself alone in the away end at a Norwich v Ipswich football match. As the match intensified, tensions rose amongst the fans. In the last minute of the game, Ipswich equalized, resulting in a surge of excitement from the crowd. Tragically, this surge led to our client being crushed by fans, causing both physical and psychological injuries.

One of the critical factors that exacerbated this situation was the lack of proper communication channels available to the security guard. Without a form of radio communication, she was unable to call for backup or receive assistance during the incident. The absence of effective communication only served to worsen an already perilous situation.

Battle for justice

When our client sought compensation for her injuries, she faced an initial denial of liability from the security company. However, with meticulous effort and determination, from solicitors at NV Legal, we built a compelling case to prove the company’s negligence and establish their responsibility in the incident. The evidence highlighted the absence of essential safety measures, including communication devices and crowd control protocols.

As liability was denied, proceedings were issued in court, and after the first directions hearing the defendant admitted responsibility for the incident and we were able to achieve a favourable outcome for our client. The security company accepted responsibility for their negligence and agreed to pay her £62,500 as compensation for the physical and psychological trauma she endured.

Workplace safety measures for security guards

Crowd management and control : Security guards should be trained to effectively manage and control crowds, especially in high-traffic areas or events. They need to be aware of crowd dynamics, potential risks, and how to prevent situations from escalating into dangerous scenarios.

Emergency procedures : Security guards must be well-versed in emergency procedures and protocols specific to their workplace. This includes knowledge of evacuation routes, assembly points, fire safety procedures, and first aid techniques. They should also be familiar with the location and proper use of emergency equipment such as fire extinguishers or defibrillators.

Security threats and risk assessment : It is crucial for security guards to be aware of potential security threats and conduct regular risk assessments. They should be trained to identify suspicious activities, recognise signs of danger, and report any unusual or concerning behaviour to the appropriate authorities. This includes being vigilant about potential theft, vandalism, trespassing, or unauthorised access to restricted areas.

Personal safety and self-defence : Security guards need to prioritise their own personal safety and be equipped with the necessary skills for self-defence. They should receive training in self-defence techniques, conflict resolution, and de-escalation strategies to handle confrontational situations effectively and protect themselves from harm.

Communication and reporting : Effective communication is essential for a security guard to maintain a safe work environment. They should have reliable means of communication, such as radios or mobile devices, to report incidents, request assistance, or relay important information. Security guards must also be proficient in accurately documenting and reporting incidents, accidents, or any suspicious activities for further investigation.

The significance of workplace safety

Our case study serves as a stark reminder of the vital importance of prioritising workplace safety. Here are a few key reasons why employers must take workplace safety seriously:

Employee well-being : Employers have a moral and legal responsibility to ensure the well-being of their employees. A safe and secure working environment is crucial for promoting physical and mental health and preventing accidents and injuries.

Productivity and performance : When employees feel safe and protected at work, they are more likely to be motivated, engaged, and productive. A culture of safety fosters trust and empowers individuals to focus on their tasks without unnecessary worry or distraction.

Reputation and brand image : Organisations that prioritise workplace safety demonstrate their commitment to the welfare of their employees and the community. Such a reputation can significantly enhance their brand image and attract top talent, customers, and business partners.

Legal compliance : Compliance with workplace safety regulations is not only ethically imperative but also legally mandated in many jurisdictions. Failure to meet these requirements can lead to severe legal consequences, including fines, penalties, and even criminal charges.

Cost savings : Investing in workplace safety measures can save organisations from incurring substantial costs associated with accidents, injuries, medical expenses, legal battles, and compensation claims. Preventing incidents is far more cost-effective than dealing with the aftermath.

Is your company doing enough?

The case study of the female security guard who suffered injuries during a football match underscores the significance of workplace safety. Employers must recognise the value of ensuring a secure environment for their employees, not only for their well-being but also for the overall success and reputation of the organisation.

By taking workplace safety seriously, employers can protect their workforce, mitigate risks, and foster a culture of care and responsibility.

If you have been affected by any of these issues, contact us for FREE legal advice. CONTACT US HERE

NV Legal has a specialist team of solicitors who are experts in relation to accidents in the workplace. If you or someone you know has questions about these issues, contact us for free legal advice.

Advice is from qualified solicitors, regulated by the Solicitors Regulation Authority.

Call – 03308 281 586

Email – [email protected]

Website – www.nvlegal.co.uk

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• What can Safety Cases offer for patient safety? A multisite case study
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• http://orcid.org/0000-0003-4981-1210 Elisa Giulia Liberati 1 ,
• http://orcid.org/0000-0003-1979-7577 Graham P Martin 1 ,
• http://orcid.org/0000-0001-9514-1890 Guillaume Lamé 1 , 2 ,
• Justin Waring 3 ,
• http://orcid.org/0000-0001-7356-5342 Carolyn Tarrant 4 ,
• http://orcid.org/0000-0002-7886-3223 Janet Willars 4 ,
• Mary Dixon-Woods 1
• 1 THIS Institute (The Healthcare Improvement Studies Institute), Department of Public Health and Primary Care , University of Cambridge , Cambridge , UK
• 2 Laboratoire Genie Industriel , CentraleSupélec, Paris Saclay University , Gif-sur-Yvette , France
• 3 Health Services Management Centre , University of Birmingham , Birmingham , UK
• 4 Department of Population Health Sciences , University of Leicester , Leicester , UK
• Correspondence to Dr Elisa Giulia Liberati, THIS Institute (Public Health and Primary Care), University of Cambridge, Cambridge, UK; elisa.liberati{at}thisinstitute.cam.ac.uk

Background The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways.

Methods Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams.

Results The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm.

Conclusions The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors.

• Patient safety
• Qualitative research
• Risk management

Data availability statement

No data are available.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ .

http://dx.doi.org/10.1136/bmjqs-2023-016042

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Safety Cases are a well-established regulatory technique in some areas, requiring organisations to make the case to the relevant regulator that they have put in place adequate measures to reduce risks in their systems to a level ‘as low as reasonably practicable’ (ALARP).

Importing of safety practices from other sectors has a long track record in healthcare, but little is known about the potential of the Safety Case approach when applied to clinical pathways.

WHAT THIS STUDY ADDS

It was difficult for clinical teams to use the Safety Case as intended (to show that risks had been reduced to ALARP), not least because they often identified issues that front-line staff could not address.

Safety Cases were sometimes used instead to attract senior leaders’ attention and to make the case for better support and resourcing, but some issues were beyond the control even of organisational leadership.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

Safety Cases may have some potential in healthcare, but their optimal use in this sector may require modifications, particularly if they are considered for regulatory purposes.

Introduction

Patient safety remains a major challenge for healthcare, despite more than two decades of sustained policy, practice and research attention. 1 2 The initial enthusiasm for borrowing practices and methods from other safety-critical industries (such as aviation) at the outset of the patient safety movement 3–5 has been tempered by experience. 6–12 It is now widely recognised that attempts to transfer approaches between contexts require care and caution, and should be supported by theory and empirical evaluation. 13–15 This paper seeks to contribute to addressing this need through examination of an attempt to introduce into healthcare a specific safety approach—the Safety Case—that is already used in other industries (including oil, transport and mining) both as a regulatory technique, 16 and, more rarely, as a quality management approach without regulatory mandate (eg, in the automotive industry). 17 18

The specifics of the Safety Case approach vary between sectors and regulators, 19 but the general principles are listed in box 1 . In brief, a claim to operational safety is justified through a series of linked arguments that explain how safety has been secured, with supporting evidence , including the processes in place to control risk. Where used as a regulatory technique, Safety Cases are produced by organisations to ‘make the case’ to the relevant regulator that they have put in place adequate measures to reduce risks in a product or system to a level ‘as low as reasonably practicable’ (often abbreviated as ALARP). The regulator then reviews the Safety Case and either grants the organisation licence to operate, or may require further risk assessments, justification of the measures proposed or additional risk mitigations. 20

Typical features of safety cases

Safety Cases are developed to ‘make the case’ that risk has been reduced to a level ‘as low as reasonably practicable’ (ALARP). To do so, Safety Cases integrate various forms of prospective risk management analysis, based on the idea that operators are better placed than external regulators to assess risks in their own systems. The core of the Safety Case is typically a risk-based argument and corresponding evidence to demonstrate that all risks associated with a particular system have been identified, that appropriate risk controls have been put in place, and that there are appropriate processes in place to monitor the effectiveness of the risk controls and the safety performance of the system on an ongoing basis. 23

Safety cases typically contain:

A description of the system and its operational context;

How safe the system is claimed to be and the criteria by which safety is assessed;

How hazards have been identified and how the risks they pose have been assessed;

What kind of risk control measures have been put into place and why they are effective; and

Why the residual level of risk is acceptable. 23

Safety Cases are typically reviewed and assessed by an external regulator, for example, in the nuclear or petrochemical industries in the UK. However, some industrial sectors have also deployed the approach outside of a regulatory requirement. For example, the automotive industry uses Safety Cases that are part of the ISO26262 standard, but this is not mandated by regulators. 17 18

As an approach requiring organisations to proactively describe what procedures and actions they are putting in place to control risk, Safety Cases can be contrasted with prescriptive, compliance-oriented approaches, where organisations are required to show that they have met externally imposed safety standards. 21 Because they are written for a specific system and its context of use, they are intended to be more adaptable to specific situations than generic safety standards, and also more responsive to rapid change in technologies or practices. 22

On the face of it, the Safety Case would appear to have value as an approach to safety management in healthcare, particularly in its potential for prospective identification and control of risk. However, the Safety Case approach has only rarely been used in healthcare, and only in a very limited number of applications (eg, development of information systems and medical devices). 23 24 In this article, we develop an analysis of the application the Safety Case approach within the UK National Health Service (NHS) using a case study of the first documented attempt to apply the principles of the methodology to clinical pathways. As the approach was deployed outside a regulatory context, our analysis focuses on the transferability of an approach to risk management that is proactive, structured, and tailored in nature and that presents evidence about the safety of specific clinical systems and existing mitigations in a single ‘case’ document.

Case study: the Safer Clinical Systems programme

Our analysis draws on an evaluation we conducted of a programme known as Safer Clinical Systems, which is designed to improve the safety and reliability of clinical pathways based on learning adapted from a range of hazardous industries. It seeks to enable organisations to make improvements to local clinical systems and pathways through a structured methodology for identifying risks and re-engineering systems to control risk and enhance resilience. 25 26 Use of the principles of the Safety Case approach is a centrepiece of the Safer Clinical Systems programme, although outside a regulatory context.

Funded by the Health Foundation, the Safer Clinical Systems programme was developed by a team at Warwick University and tested over a number of phases. Following initial development, a ‘testing phase’ involving eight NHS hospital sites (seven in England, one in Scotland) ran from 2011 to 2014. An ‘extension phase’ (2014 to 2016) involved further work by five of these sites and one new site.

Each participating hospital site ( table 1 ) was required to establish a multidisciplinary clinical team. Sites in the testing phase were advised by a support team of clinicians and experts, received inperson training, had access to other resources (such as a reference manual and telephone support) and were required to report their progress regularly. Sites in the extension phase had less bespoke support and were expected instead to build on their previous learning.

• View inline

Sites involved in the programme

A requirement of participating teams was that they use the Safer Clinical Systems approach to proactively assess risks and hazards in their clinical pathways and that they produce Safety Cases at the end of their projects describing the risks and how they were being mitigated. The Safety Cases were expected to be similar in format to those used in other sectors, 27 comprising a description of the clinical pathway covered, the key hazards identified through structured analysis using prescribed tools, the risk controls implemented, and, critically, a ‘safety claim’ and associated ‘confidence argument’—a pronouncement on the current safety of the system concerned, and a statement explaining how risks had been made ALARP. Rather than being presented to an external regulator, as would be the case if the Safety Case were being used as a regulatory technique, the principal intended audience in this programme was the senior leadership (executive and board level) within organisations.

Evaluation methods

To study the testing and extension phases of the Safer Clinical Systems programme, we used a mixed-methods, longitudinal design, involving interviews, ethnographic observations, and documentary analysis across the nine participating sites. The analysis we report here is based primarily on interviews and documentary analysis. Ethnographic observations (over 850 hours) provided valuable data on how clinical teams carried out their Safer Clinical Systems projects in practice in the context of existing and competing demands, but are not reported in detail here.

Across the nine sites, we conducted 89 semistructured interviews in the testing phase and 39 in the extension phase with participating clinical team members and programme leaders. Sampling at the sites sought to purposefully include a range of different roles in the programme, including the clinical leaders of each project and others. We also conducted 5 semistructured interviews in the testing phase, followed by 10 in the extension phase, with organisational senior leadership, comprising executive team/board members. Interviews explored general experiences of the programme as well as specific exploration of using the Safety Case approach. Participants were informed of the aims and commissioners of the evaluation. All interviews were conducted by experienced social scientists using topic guides ( online supplemental material 1 ). Interviews were conducted either in person or by telephone, between November 2012 and June 2016, and were digitally audio recorded and then transcribed for analysis.

Supplemental material

Analysis, conducted by EL and guided by the wider team, was based on the constant comparative method 28 combining inductive and deductive approaches. We coded interviews and observations using an inductive approach, deriving codes directly from each interview and then progressively clustering codes in higher order categories and themes. To strengthen explanatory power, this inductive strategy was complemented by theoretical concepts drawn from the wider literature.

GL and EL conducted a documentary analysis of the Safety Cases prepared by the clinical teams ( table 2 ). We used recommendations and guidelines for writing and maintaining safety cases in other sectors, 29–31 to organise the Safety Cases’ content thematically, and identified their main strengths and weaknesses in terms of completeness, presence of appropriate evidence and analyses to support the claims, consistency with the site’s safety improvement objectives, readability, and presence of a safety claim and confidence argument.

Format and content of 13 Safety Cases reviewed

Finally, we organised our higher order themes and overall reflections using concepts and themes proposed by recent works on the topic. 19 32 Regular team meetings and correspondence provided oversight of the analytical approach, consistency and adequacy of codes, and reporting. Given the nature of the programme, we did not undertake a formal test for theoretical saturation for the interviews or the Safety Cases.

Across the testing and extension phases of Safer Clinical Systems, we undertook 143 interviews with participants across programme leadership, clinical teams and organisational leadership. We analysed 13 submitted Safety Cases; although 14 should have been developed, one site from the extension phase struggled to implement the programme in full and did not produce a Safety Case.

In presenting our analysis below, we consider, first, participants’ views on the Safety Case as a novel approach to understanding and managing safety risk in healthcare, and second, the work that went into developing Safety Cases. We then turn to the analysis of Safety Cases themselves.

Views on the value of safety cases

By the end of the programme, members of the project teams and senior leadership in the participating organisations had largely come to see the Safety Case as a valuable approach, with the potential to make hazards visible in an accountable, systematic and scientific way. The analytical steps required to compile a Safety Case, such as process mapping the patient pathway, were seen to be particularly useful in proactively identifying threats to safety, rather than reactively managing incidents once they had happened. The role of Safety Cases in enabling an overarching, system-wide view of the hazards, rather than focusing on what happens in particular segments of the pathway, was also welcomed. Broadly, teams valued the possibilities of new ways of thinking about risk.

I like the idea that you just have one document that you can hand to somebody and say how safe is your system. I like the concept that you can say ‘Well this is what our system is like just now’. (Project participant)

Some organisational senior leaders agreed, at least in principle, that Safety Cases could offer value, and recognised the importance of a prospective approach to safety.

We have immensely complex systems which could be simplified and therefore made a bit more reliable. […] So something which looks at that could certainly be a useful thing, because it’s saying ‘Well actually here is a little nest of complexity which you can reduce, but it’s also a significant risk to the patient, because you’re missing information or you’re hurrying things through.’ […] (Senior leader)

Other senior leaders, however, were not always clear on the practicalities of the approach, and some found it difficult to identify the added value of Safety Cases. They suggested, for example, that existing risk management tools performed very similar functions.

If you look at our risk register, mitigation is the last box, we spend a good amount of time on the other things, but if we were to spend any time on a particular risk it would be on mitigation […]. And so that sounds like a very similar process, and so I’m back to what the delineation is between Safety Case and risk register. (Senior leader)

Some project teams saw the Safety Case as useful for a secondary reason: that of securing the attention and interest of senior leaders in their organisations. Their hope was that, by providing new evidence and analysis of the riskiness of clinical systems, senior management attention, support, and resources might be solicited.

So they’ve [senior management] actually kind of bought into it, so I think they will feel pressure to deliver. (Project participant)

However, as we explain below, the exact fit of Safety Cases into the existing ecology of tools and documents in healthcare was not clear to all participants.

Preparing safety cases

Project teams were required to learn new techniques to prepare the Safety Cases, including use of systematic methods to identify and assess risks in their clinical pathways, to propose risk controls and to identify metrics that could be used to monitor systems. Production and communication of Safety Cases also required skills in making persuasive claims, structuring arguments and presenting evidence compellingly. The participating teams were, understandably, unfamiliar with many of these skills, and expressed uncertainties about the expected structure, content and style of the Safety Case itself, especially in terms of what issues to emphasise and how to evidence them. Participants described compiling and drafting the Safety Case as labour-intensive and difficult.

I think the other bit that we have been challenged by is the actual writing of the Safety Case and again it is because it is fairly new to healthcare in general. I think we are going to go through a few reiterations before we fully understand what it is and how to use it. (Project participant)

Notwithstanding the training and support received in the ‘testing’ phase, teams continued to report difficulties with preparing and drafting Safety Cases well into the extension phase. A recurrent source of ambiguity related to the size and scope of the clinical system that the Safety Cases should target. The first, diagnostic, step in the Safer Clinical Systems process involved defining the clinical pathway of focus. However, determining the boundaries of the pathway was far from straightforward. Furthermore, clinical pathways typically involved dozens of technological systems (eg, infusion pumps, IT systems) and sociotechnical processes (eg, guidelines, multidisciplinary meetings). Each might be amenable to risk assessment and management individually, but making sense of their connections, aggregate risks and potential interactions was a much more complex task.

It’s not a linear process and you do go back trying to understand another bit of the process that you thought you understood, but actually didn't as (…) you had hoped. (Project participant)

Once the pathways and their components had been determined (or at least approximated), project teams used a range of methods recommended by the Safer Clinical Systems programme, mostly derived from similar activities in other industries, to assess hazards and risks. The teams found the processes often challenging and time-consuming, with much discussion about the relative merits of different sources of data and evidence. Despite the challenges, teams generally concluded that conducting a systematic risk assessment using structured tools offered important new insights about clinical pathways.

What I’ve loved doing is, is talking to the staff and actually understanding what goes on, because it’s only when you understand what goes on that you can put it right… You’ve worked in the hospital for years and there’s still things you didn’t realise actually went on and things that people did that you didn't realise that they actually did. That was quite an eye-opener. (Project participant)

This new understanding through structured risk assessment enabled teams to identify multiple shortcomings that had potential to harm patients. The hazards they unearthed varied greatly in scale, level of risk posed and tractability to intervention. Some problems identified were amenable to resolution by the project teams, typically those with their roots in suboptimal service planning and pathway design, failures in communication among staff, or unclear distribution of responsibility or ownership of key processes. In response to these, most, but not all, sites designed or implemented some risk controls and documented them in their Safety Cases.

[Staff are] given the freedom and the autonomy to go ahead and do whatever things they think might be necessary to make things better. And that’s what people do, there is very much a culture of promoting change there, so they talked about small cycles of change, doing PDSA [Plan Dp Study Act] cycles, and there’s a number of different projects that are running (Observation notes)

The extent to which these risk control interventions were consistent with the principles of the Safer Clinical Systems programme varied by site. Some project teams were able to draw on extensive experience, while others foundered at this stage. Common to all sites, however, was the identification of issues that were well beyond the scope of control of the front-line teams themselves. These vulnerabilities tended to originate from deep-rooted institutional and organisational pathologies or constraints. The importance of these problems, including, for example, staffing levels, was beyond doubt. Exactly what to do about them was less clear. Some project teams made valiant attempts to at least mitigate the risks through local work, but others appeared to accept that standard quality improvement efforts would not solve the issues. Some teams described the ongoing failure to mitigate the risks in their Safety Cases, in part, as noted above, in the hope that action from senior level might be provoked.

There were other things that were discussed at the [meeting] that they thought would be good as a team to change… but with some of them, they just knew it would be impossible to do so, so actually they didn't even bother to write them down. (Observation notes) And the team very bravely went to the board and said, you know, our Safety Case is showing and we're telling you that our processes are unsafe, so it alerted people to the issues. […] So that was the strength of it. (Project participant)

However, as we now describe, for senior organisational leaders, both the imperative offered by the Safety Case and their own ability to act were less clear.

Content of, and responses to, safety cases

Our documentary review showed that submitted Safety Cases were highly variable in format and length ( table 2 ). Some were highly structured, clearly written and precise in the use of evidence; others were harder to follow, lacking in clarity and less well organised. Our review also found that the descriptive elements (analysis of risk and hazards) were much better achieved than the assurance components (the safety claim and the confidence argument). Indicative, perhaps, of the intractability to local-level intervention of some of the hazards uncovered, or the lack of expert safety science input in the project teams, most Safety Cases focused more on what had been done to determine the risk than on the level of safety that had been achieved in mitigating it. The documents also varied in the extent to which they reported the residual risks—those that remained despite the implementation of risk controls—in a clear and transparent way. For instance, one Safety Case noted that the diagnostic process had found 99 ways in which the pathway could fail, that the level of reliability in the microsystem remained lower than acceptable, and that radical re-design was needed. Others were more circumspect. Accordingly, while they documented sometimes-extensive mitigations, none of the Safety Cases could make an unambiguous safety claim supported by a powerful confidence argument. Some teams were not clear about how the evidence gathered and analyses conducted would contribute to the safety claim. Some sites listed project activities in lieu of offering an actual safety claim, reporting what they had done rather than the level of safety they had reached.

It was a useful, […] a really good repository for all the stuff we've done in the project, which I find really good. And has been good when people ask ‘What did you do?’ then you can say that this is what we did, so that’s useful. I'm not sure about whether people use it for what it is meant to be, which is to prove the pathway is now safe, I’m not sure whether it is used for that really. (Project participant)

Sometimes, safety claims were reported for each identified hazard (comparing levels of risk before and after the interventions they had implemented) rather than at the level of the clinical system. No site explicitly discussed whether risks had been reduced ‘as low as reasonably practical’. Some sites claimed improvements as a result of the interventions they had implemented, but these did not always stand up to statistical scrutiny. 33

The response of senior leadership to the Safety Cases submitted by teams varied. Some focused on the potential of the Safety Case for supporting organisational-level decision making in relation to risk reduction, resource allocation and strategic prioritisation.

I think it would be easier to respond to a Safety Case rather than more so the [other quality and safety] data I get. Because it’s back to first principles, what are we actually here to do… Then if we have an unsafe system everything else needs to fall in behind that, no matter cost pressures, no matter personal opinion, no matter all the other complexities in a big system. If an element is at risk, then that will always be made a priority. (Senior leader)

Not all senior leaders, however, were so confident that the insight offered by Safety Cases would or should inevitably lead to action. Some of the issues identified in the Safety Cases were beyond the ability not only of front-line teams to solve, but also of organisational leaders. Issues such as staffing levels, IT interoperability, and securing timely discharge required at least interorganisational coordination, resourcing, coordination, and support across the whole healthcare system. Additionally, the prevailing approach to risk management, and the perceived unavoidability of risks in the complex systems of healthcare, meant that the insights offered by a Safety Case might be unwelcome or not necessarily candidates for priority attention. In a system that relied primarily on retrospective risk management approaches, such as incident reporting and investigations, the need to tackle risks of recurrence (where problems had already manifested as serious incidents or ‘near misses’, and might do again) could easily take precedence over addressing seemingly ‘theoretical’ risks (problems identified through a detailed prospective analysis but yet to occur).

Because you’re saying actually ‘That was a potential harm on our risk management system, and we knew about it, and we were accepting that we don’t have enough money to address all of these issues at one time’. So there is, if you like, a prioritisation and rationing of where we put money according to the level of risk. […] It’s a bit like county councils putting crossings on roads, or a zebra crossing. You’re waiting for the fatality to occur before actually that will get the funding. (Senior leader)

Some feared that, given the legal obligation of boards to take action in response to safety risks that were revealed to them, an unintended consequence of the Safety Case approach might be to distract organisational focus from areas that were at least as worthy of attention but lacked the spotlight offered by the Safety Case. There was a perception that to have a Safety Case for every pathway or area of practice would likely be impossible, and that too many Safety Cases would be overwhelming.

The complexity of health care is such that there are hundreds of complex connected pathways that patients are on and so… You in theory could write hundreds [of Safety Cases] and that would then become meaningless because if you write hundreds no one would ever read them. So, I think it might be helpful in some specific examples… Rather than being something that could cover everything that we do to patients. (Senior leader)

Consequently, Safety Cases might serve not to assure about control of risks, but to unnerve—and unnerve leaders who were not always well placed to act, given the scope of their control and the other priorities they faced. In a system where Safety Cases were new, without an established function in safety management, and covering only a small proportion of safety-critical activity, the information they provided was not always readily actionable from a managerial perspective and, moreover, had potential to create uncontrolled reputational risk.

The danger is that what you have is a legal requirement to spend money on a Safety Case that actually is of low, relative risk to harms that are occurring in the absence of Safety Cases. So what you get is a spurious diversion of money to a wheel that has been made very squeaky, but actually isn’t causing harm… There’s the risk of diversion to get a perfect patch in one part of the system while everything else is actually terrible. (Senior leader) (A danger) is, you know, if it does get into the wrong hands, particularly with the media, because there’s not the openness and the ability to manage some of this data, which needs explanation. But we do pride ourselves on being a very open and transparent board. (Senior leader)

Our examination of an attempt to introduce the principles and methodologies of the Safety Case approach into healthcare suggests that the approach was broadly welcomed by participants in our study, but was fraught with challenge. In other sectors, the Safety Case rests on the ALARP principle. While the Safety Cases produced by participating teams in the Safer Clinical Systems programme did present proactive analyses of risks, they did not show that the risks in clinical pathways on which they focused had been reduced as far as reasonably possible. Instead, teams identified multiple residual risks that had resisted efforts at control and mitigation by the teams themselves. These findings emphasise the importance of careful consideration of context and implementation when transferring safety management approaches from one setting to another. 12 34–36 The evidence underlying other industrial risk management techniques (eg, Failure Modes and Effects Analysis, 37 ‘5 Whys’ 10 or Root Case Analysis 11 ) is also weak, but the regulatory function of Safety Cases warrants specific caution. Sujan et al ’s review of various sectors nonetheless concluded that even with the differences in regulatory context, healthcare organisations could benefit from using the Safety Case approach to develop understanding and exposition of their current levels of risk. 19 Our study does suggest that Safety Cases show some promise as a way of structuring more responsive, adaptable and specific proactive safety management practices in healthcare settings, but further careful development and evaluation are needed, particularly if consideration is given to using them for regulatory purposes. 19

An important feature of the programme we examined—essentially a feasibility study—was that the Safety Case approach was being used outside the regulatory frameworks and infrastructures characteristic of use of the technique in most other sectors. Without an external regulatory requirement to satisfy, participating organisations in the Safer Clinical Systems programme may not have felt a strong imperative to make the responses that might otherwise be expected; absent the spectre of regulatory action, senior leadership may not have felt compelled to reduce the risks ALARP. However, even when Safety Cases are part of a regulatory framework, they are not always rigorous or successful in controlling risk 38 or showing they have been reduced ALARP. 39 While our study does not allow conclusions to be drawn about what might happen if Safety Cases were included in a regulatory regime in healthcare, it does allow insights into the nature of the challenges that might be anticipated should regulators consider introducing the approach in healthcare settings.

Some of the challenges we identified arose from the mismatch between the complexity and interdependencies of clinical pathways, with their often unbounded character, and the more tightly defined (and often more mechanical or technical) applications of the approach in other industries. 22 40 Future research might usefully clarify whether and how the scope of a Safety Case could best be defined for healthcare settings, noting that the highly dynamic and interdependent nature of multiple subsystems of care may defy attempts to impose clear boundaries. These kinds of questions are becoming increasingly prominent in safety science as recognition grows that the development of networked complex systems (eg, unmanned aircraft systems) requires a shift from relatively static prelaunch assessment to a dynamic approach that can accommodate changes in the system’s properties and behaviour during its life-cycle. 41 42

Other challenges arose in the demanding nature of the expertise, skill and time commitment required to engage in the tasks of conducting safety analyses, identifying and testing risk controls, and compiling a Safety Case. The variable quality of the Safety Cases submitted by clinical teams in this programme is likely to be linked to variable competencies and available capacity. In contrast, in safety-critical industries where these risk assessment techniques originated, the design of effective risk controls is the responsibility of safety/reliability engineers with extensive training and expertise. For healthcare, use of the Safety Case approach will require additional resource and new dedicated roles with specific expertise, rather than relying on making further demands of existing clinical teams. 40 43 The resourcing implications of a wholesale effort to shift the regulatory system and culture of an entire sector could, however, be enormous, especially given the volume and complexity of activity in healthcare and the number of diverse clinical pathways.

An additional set of challenges was more cultural in character, and related to the revelatory potential of the Safety Case. On one hand, participants—especially clinical teams—appreciated the value of the Safety Case in offering a proactive, prospective and rigorous approach to identifying safety risks. Some also saw it as a means of attracting managerial attention and obtaining resources. 44 But leaders in organisations were not always convinced that the approach offered much that was new, suggesting that more evidence would be needed to demonstrate the added value of Safety Cases—especially in moving beyond description to solution, 45 and adding value over current approaches such as risk registers. A further concern at the leadership level was that it was unclear whether areas that did have a Safety Case should be considered to have a stronger warrant for action than those that did not. A framework for supporting prioritisation of risks is likely to be helpful in any future use of Safety Cases. However, current tools, such as risk matrices, may be flawed, 46 47 so better tools should be investigated.

Even less tractable was what to do about some of the problems reported in the Safety Cases. Clinical teams had done their best to implement risk controls where they could, but they did not have sufficient power and access to resources to address those that were institutional or structural in character. They therefore often fell back on weaker administrative measures, like training or procedures. 8 Yet organisational leaders were often similarly challenged, given their limited capacity and resources for radical systems re-design, improved staffing, IT infrastructure, or other major re-engineering or influencing of activities outside the organisation itself. These findings are indicative of broader problems with the selection of risk controls in health services 44 48 that may need to be addressed before Safety Cases could achieve their potential.

Our study has a number of strengths, including its in-depth, mixed-methods, longitudinal design with engagement both with the project teams and senior leaders in organisations. It was limited in its ability to assess the impact of the Safety Case approach in improving safety, not least because of issues with data on processes and outcomes. 33

Conclusions

The Safety Case approach offers promise in principle as a safety management approach in healthcare, but substantial challenges need to be addressed before further deployment, particularly in regulation. Further experimentation with the use of Safety Cases in healthcare might therefore more profitably focus on how to make the most of their assets—including the new insights offered by prospective, system-wide risk analysis—while managing their potential unintended consequences.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

This study involves human participants and was approved by the East Midlands – Leicester Research Ethics Committee (12/EM/0228). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

We thank the people from the nine sites who participated in the Safer Clinical Systems programme and the support team. We also thank colleagues on the evaluation team, including Sarah Chew, Liz Shaw, Liz Sutton, and Lisa Hallam.

• Illingworth J ,
• Fernandez Crespo R , et al
• Panagioti M ,
• Keers RN , et al
• Dixon-Woods M ,
• Goeschel CA , et al
• Catchpole K ,
• Liberati EG ,
• Peerally MF ,
• Dixon-Woods M
• Waring J , et al
• Radnor ZJ ,
• Marshall M ,
• Pronovost P ,
• Auerbach AD ,
• Landefeld CS ,
• Shojania KG
• Portela MC ,
• Pronovost PJ ,
• Woodcock T , et al
• Cleland G ,
• Kelly TP , et al
• Cleland GM ,
• Sujan M , et al
• Spurgeon P ,
• Flanagan H ,
• Cooke M , et al
• Hawkins R , et al
• UK Ministry of Defence
• Haddon-Cave C
• Woodcock T ,
• Soukup T , et al
• Lincoln J , et al
• Franklin BD ,
• Rivera AJ , et al
• Borg J , et al
• Fairbanks RJ
• Braithwaite J
• Naghavi M ,
• Foreman K , et al
• Clarkson PJ

Supplementary materials

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Twitter @graham_p_martin, @carolynctarrant

Contributors EL and GL produced the first draft of the article, subsequently revised by GM, JWa, and MD-W. EL and JWi collected the data, analysed by EL and GL. All authors contributed to data interpretation, manuscript writing and reviewing, and approved the final version. MD-W was the study Chief Investigator and study guarantor.

Funding This study was funded by the Health Foundation, charity number 286967. The Healthcare Improvement Studies (THIS) Institute is supported by the Health Foundation – an independent charity committed to bringing about better health and health care for people in the UK. The views expressed in this publication are those of the authors and not necessarily those of the Health Foundation.

Competing interests None declared.

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Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Safety Cases and Their Role in ISO 26262 Functional Safety Assessment

• John Birch 19 ,
• Roger Rivett 20 ,
• Ibrahim Habli 21 ,
• Ben Bradshaw 22 ,
• John Botham 23 ,
• Dave Higham 24 ,
• Peter Jesty 25 ,
• Helen Monkhouse 26 &
• Robert Palin 27  
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Compliance with the automotive standard ISO 26262 requires the development of a safety case for electrical and/or electronic (E/E) systems whose malfunction has the potential to lead to an unreasonable level of risk. In order to justify freedom from unreasonable risk, a safety argument should be developed in which the safety requirements are shown to be complete and satisfied by the evidence generated from the ISO 26262 work products. However, the standard does not provide practical guidelines for how it should be developed and reviewed. More importantly, the standard does not describe how the safety argument should be evaluated in the functional safety assessment process. In this paper, we categorise and analyse the main argument structures required of a safety case and specify the relationships that exist between these structures. Particular emphasis is placed on the importance of the product-based safety rationale within the argument and the role this rationale should play in assessing functional safety. The approach is evaluated in an industrial case study. The paper concludes with a discussion of the potential benefits and challenges of structured safety arguments for evaluating the rationale, assumptions and evidence put forward when claiming compliance with ISO 26262.

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ISO: ISO 26262 Road Vehicles– Functional Safety. ISO Standard (2011)

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Graydon, P., Habli, I., Hawkins, R., Kelly, T., Knight: Arguing conformance. IEEE Software 29(3) (2012)

Bishop, P., Bloomfield, R.: A methodology for safety case development. In: Proc. 6th Safety-critical Sys. Symp. (1998)

Kelly, T.: A systematic approach to safety case management. In: Proc. Society of Automotive Engineers (SAE) World Congress (2004)

The Health Foundation, Using Safety Cases in Industry and Healthcare (2012) ISBN: 978-1-906461-43-0

Dittel, T., Aryus, H.-J.: How to “Survive” a safety case according to ISO 26262. In: Schoitsch, E. (ed.) SAFECOMP 2010. LNCS, vol. 6351, pp. 97–111. Springer, Heidelberg (2010)

CrossRef   Google Scholar  

Palin, R., Habli, I.: Assurance of automotive safety – A safety case approach. In: Schoitsch, E. (ed.) SAFECOMP 2010. LNCS, vol. 6351, pp. 82–96. Springer, Heidelberg (2010)

Habli, I., Kelly, I.: Process and product certification arguments: getting the balance right. SIGBED Review 3(4) (2006)

Langari, Z., Maibaum, T.: Safety cases: a review of challenges. In: International Workshop on Assurance Cases for Software-intensive Systems (ASSURE 2013), San Francisco (2013)

Denney, E., Pai, G., Habli, I.: Towards measurement of confidence in safety cases. In: Proc. 5th Intl. Symp. on Empirical Soft. Eng. and Measurement, pp. 380–383 (September 2011)

Ayoub, A., Kim, B., Lee, I., Sokolsky, O.: A systematic approach to justifying sufficient confidence in software safety arguments. In: Ortmeier, F., Lipaczewski, M. (eds.) SAFECOMP 2012. LNCS, vol. 7612, pp. 305–316. Springer, Heidelberg (2012)

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Birch, J. et al. (2013). Safety Cases and Their Role in ISO 26262 Functional Safety Assessment. In: Bitsch, F., Guiochet, J., Kaâniche, M. (eds) Computer Safety, Reliability, and Security. SAFECOMP 2013. Lecture Notes in Computer Science, vol 8153. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-40793-2_15

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