Purpose: There is a growing awareness on the use of systems approaches to improve patient safety and quality. While earlier studies evaluated the validity of such approaches to identify and mitigate patient safety risks, so far only little attention has been given to their inputs, such as structured brainstorming and use of system mapping approaches (SMAs), to understand their impact in the risk identification process. To address this gap, the purpose of this paper is to evaluate the inputs of a well-known systems approach, failure modes and effects analysis (FMEA), in identifying patient safety risks in a real healthcare setting. Design/methodology/approach: This study was conducted in a newly established adult attention deficit hyperactivity disorder service at Cambridge and Peterborough Foundation Trust in the UK. Three stakeholders of the chosen service together with the facilitators conducted an FMEA exercise along with a particular system diagram that was initially found as the most useful SMA by eight stakeholders of the service. Findings: In this study, it was found that the formal structure of FMEA adds value to the risk identification process through comprehensive system coverage with the help of the system diagram. However, results also indicates that the structured brainstorming refrains FMEA participants from identifying and imagining new risks since they follow the process predefined in the given system diagram. Originality/value: While this study shows the potential contribution of FMEA inputs, it also suggests that healthcare organisations should not depend solely on FMEA results when identifying patient safety risks; and therefore prioritising their safety concerns.

Quality problem or issue: A number of challenges have been identified with current risk assessment practice in hospitals, including: a lack of consultation with a sufficiently wide group of stakeholders; a lack of consistency and transparency; and insufficient risk assessment guidance. Consequently, risk assessment may not be fully effective as a means to ensure safety. Initial assessment: We used a V system developmental model, in conjunction with mixed methods, including interviews and document analysis to identify user needs and requirements. Choice of solution: One way to address current challenges is through providing good guidance on the fundamental aspects of risk assessment. We designed a risk assessment framework, comprising: a risk assessment model that depicts the main risk assessment steps; risk assessment explanation cards that provide prompts to help apply each step; and a risk assessment form that helps to systematize the risk assessment and document the findings. Implementation: We conducted multiple group discussions to pilot the framework through the use of a representative scenario and used our findings for the user evaluation. Evaluation: User evaluation was conducted with 10 participants through interviews and showed promising results. Lessons learned: While the framework was recommended for use in practice, it was also proposed that it be adopted as a training tool. With its use in risk assessment, we anticipate that risk assessments would lead to more effective decisions being made and more appropriate actions being taken to minimize risks. Consequently, the quality and safety of care delivered could be improved.