External Beam Radiotherapy Techniques —
Training activity: 20

Details

Audit the department’s processes against the current legislative landscape for software development or implementation.

Type

Developmental training activity (DTA)

Evidence requirements

Evidence the activity has been undertaken by the trainee​.

Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.

An action plan to implement learning and/or to address skills or knowledge gaps identified.

Reflective practice guidance

The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.

Before action

What are the intended outcomes of the training activity?

• How can you frame this audit to ensure it directly addresses the requirement to apply guidance, regulations, and codes of practice to maintain patient safety within software-driven radiotherapy processes?
• What specific legislative frameworks or national/international guidance (such as Medical Device Regulations or IPEM reports) do you need to review to contextualise your preparation for this software audit?
• How will you ensure that your audit allows you to interpret findings in a way that can be effectively disseminated to the wider multidisciplinary team?
• What do you need to understand about the quality management system and its relationship with clinical software before you begin the evaluation?

What do you anticipate you will learn from the experience?

• What specific insights do you hope to gain regarding the interconnectedness of software implementation, regulatory compliance, and the overall framework of radiotherapy safety?
• How do you anticipate this activity will deepen your understanding of the Clinical Scientific Computing role in the radiotherapy patient pathway?
• What do you already know about audit methodologies, and how might you apply that knowledge to the specific context of software development or upgrades?
• How might this experience help you identify the transferable skills required to critically assess and lead the commissioning of new technology in the future?

What actions will you take in preparation for the experience?

• How will you structure your initial discussion with your Training Officer or a clinical computing specialist to gain clarity on the current legislative landscape affecting your department?
• What potential challenges do you anticipate, such as identifying gaps in documented procedures or interpreting complex software-related safety interlocks?
• How do you feel about the prospect of auditing these technical processes, and what steps can you take to manage any concerns about working within your scope of practice?
• Which departmental quality system documents or local rules should you gather in advance to use as a benchmark for your audit findings?

In action

What are you doing?

• How are you approaching the audit of the software landscape to ensure you are capturing the most critical processes related to patient safety and regulatory compliance?
• What decisions are you making as the audit progresses regarding which pieces of evidence (such as commissioning data or validation reports) require the most scrutiny?
• Which aspects of interpreting the legislative landscape for software feel intuitive to you, and which specific codes of practice or safety interlocks require more conscious effort to evaluate?
• Why are you choosing specific audit methodologies at this moment to verify that the quality management system adequately covers software development or upgrades?

How are you progressing with the activity?

• How effective do your current actions feel in identifying potential gaps between local departmental practice and national or international software standards?
• What challenges are you facing as you attempt to verify the traceability of software-related measurements or the accuracy of dose calculation algorithms?
• What are you learning as the audit unfolds about the interconnectedness of software performance, clinical workflow, and treatment accuracy?
• How does this audit activity connect to your existing knowledge of radiotherapy safety systems and the role of Clinical Scientific Computing professionals in the patient pathway?

How are you adapting to the situation?

• Are there alternative approaches you should consider right now to better capture how the department manages software-related risks to patients?
• What specific support or guidance do you need in this moment from your Training Officer or a clinical computing specialist to interpret a complex legislative requirement?
• How are you ensuring that you are working within your scope of practice while evaluating high-level technical software specifications?
• As you identify findings, how are you already adapting your communication style to ensure the results can be effectively disseminated to a multidisciplinary team later?

On action

What did you notice?

• How would you summarise the key points of your audit, specifically regarding how the department’s software development or implementation processes currently align with the legislative landscape?
• What were the most significant aspects of the legislative frameworks or national guidance (e.g., IPEM or Medical Device Regulations) that you identified as being most relevant to the software used in external beam radiotherapy?
• When reviewing the quality management system or local rules, what did you observe regarding the clarity and accessibility of documentation for software-related safety interlocks or upgrades?
• What were the main findings of your audit report, and what specific discrepancies did you notice between documented codes of practice and actual clinical software implementation?

What did you learn from the activity?

• What specific knowledge of regulations and guidance did you develop to ensure that software-driven elements of practice maintain patient safety?
• In what ways did this experience improve your ability to perform audits in a technical context and interpret complex findings for a wider audience?
• Were there any unexpected challenges during the audit, such as finding that a local software modification lacked sufficient validation data or commissioning reports, and what did you learn from these?
• How did your reflection-in-action (the decisions you made while conducting the audit) influence how you gathered evidence or interacted with Clinical Scientific Computing staff?
• How does this audit experience relate to your future requirements as a Clinical Scientist who must justify the commissioning and quality assurance of new software technology?

What will you take from the experience moving forward?

• What areas for continued development have you identified regarding your ability to critically appraise software risk assessments or dose calculation algorithms?
• How can you apply the learning from this audit—such as the importance of traceability and validation—to your routine practice when using or upgrading a treatment planning system?
• What next steps will you take to ensure your audit findings are used to support the assimilation of safety standards within the department?
• How will you approach the task of disseminating your findings and recommendations to the multidisciplinary team to advocate for continuous improvement in software safety?
• What further support or resources might you need, such as advanced training in radiotherapy software commissioning, to further develop the areas you have identified through this reflection?

Beyond action

Have you revisited the experiences?

• As you evaluate and re-evaluate this audit experience, how has your perspective on the legislative landscape for software changed now that you have more experience with clinical software commissioning or upgrades?
• When you compare this software audit with Observed Training Activities (OTAs), what consistent observable practices regarding data integrity and patient safety have you assimilated into your routine work?
• How has engaging in professional storytelling with Clinical Scientific Computing healthcare professionals influenced your view of how software-related safety interlocks and codes of practice are integrated into the radiotherapy patient pathway?
• As you revisit reflections from other auditing training activities, such as auditing local rules or the overall quality assurance programme, what common themes can you identify regarding your ability to identify gaps in complex systems?

How have these experiences impacted upon your current practice?

• How do you recognise this software audit not as an isolated incident, but as a building block for developing transferable skills such as interpreting findings and disseminating information to a multidisciplinary team?
• In what ways have you applied the knowledge of national and international guidance (e.g., IPEM or AAPM) gained during this audit to your current daily tasks, such as routine quality assurance or beam data handling?
• How has the experience of assessing software against legislative requirements supported your readiness for in-person assessments, such as Case-based Discussions (CBDs), where you must justify the safety and efficacy of treatment planning algorithms?
• How has your wider practice been influenced by the interconnectedness you discovered between software-related measurements and the traceability required for patient safety?

How might these experiences contribute towards your future practice?

• What transferable skills have you identified through this activity—such as the ability to perform a risk-benefit analysis for new technology—that will be essential for your future role as a Clinical Scientist?
• What clear actions for continued development will you take, such as seeking to lead the drafting of a commissioning plan for a new technology or technique?
• How will this experience influence your future involvement in auditing quality management systems to ensure that software updates always maintain the highest standards of patient safety?
• How do you intend to use the skills developed in this audit to advocate for continuous improvement in departmental practices and the adoption of advanced software standards throughout your career?

Relevant learning outcomes

#	Outcome
# 3	Outcome Apply appropriate guidance, regulations and codes of practice to ensure patient safety in all elements of practice.
# 8	Outcome Perform audits in a variety of contexts and interpret their findings, disseminating information to others as appropriate.