Training activity information
Details
Assess and deal with unplanned deviations relating to radiopharmacy production
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.
Considerations
- National legislation and guidance
- Unit SOPs
- Local rules
- Troubleshooting, prioritisation and decision making
- Safe working practices
- Critical incident reporting
- Capacity planning
- Contingency planning
- Quality risk management
- Risk assessment
- Communication with patients
- Communication with other departments
- Change control
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 constitutes an unplanned deviation in radiopharmacy production?
- What are the local procedures for identifying, documenting, and assessing unplanned deviations?
- What are the different categories of deviations and the expected levels of investigation and corrective action?
- Who is responsible for authorising and implementing corrective and preventative actions (CAPA)?
- What are the potential impacts of deviations on product quality and patient safety?
- How will this activity enhance your ability to critically evaluate production processes and identify potential issues?
- What insights do you expect to gain into the decision-making processes involved in managing deviations and implementing effective CAPA?
- Discuss the local deviation management procedures with your training officer.
- Review examples of previous deviations and the actions taken to address them (if available and appropriate).
- Familiarise yourself with the documentation used for recording and managing deviations.
- Consider potential deviation scenarios that could arise during radiopharmacy production and how you might approach their assessment.
In action
- Pay attention to your actions as you assess and deal with the unplanned deviation.
- How are you approaching the assessment (e.g., gathering information, analysing data, consulting records)?
- How are you deciding on the appropriate course of action?
- What decisions are you making regarding the severity of the deviation, the potential impact, and the necessary corrective and preventative actions?
- What aspects of assessing deviations feel intuitive based on your understanding of pharmaceutical quality management systems, and what requires more conscious effort and reference to procedures and guidelines?
- How effective are your actions in identifying the root cause of the deviation, determining its impact, and implementing appropriate corrective actions?
- What challenges are you facing in this process (e.g., incomplete information, conflicting data, difficulty in identifying the root cause)?
- What can you learn about radiopharmacy production processes, potential points of failure, and effective deviation management as this unfolds?
- How does this activity connect to your existing knowledge of quality assurance principles, good manufacturing practice (GMP), and risk management?
- Are there alternative approaches you could be considering for investigating the deviation or implementing solutions?
- What support or guidance might you need from quality assurance personnel or senior production staff?
- Are you ensuring your assessment and proposed actions are in line with established quality management systems and your level of responsibility?
On action
- Describe the unplanned deviation that occurred during radiopharmacy production.
- How was the deviation detected? What steps did you take to assess the nature and extent of the deviation?
- How did you consult with other team members or refer to relevant procedures while assessing and dealing with the deviation?
- What decisions did you make regarding how to address the unplanned deviation?
- What did you learn about the types of unplanned deviations that can occur in radiopharmacy production?
- How did this experience enhance your understanding of pharmaceutical quality management systems?
- What did you learn about the process of assessing the impact of a deviation and implementing corrective actions?
- Were there any unexpected challenges or learning points during the process of dealing with the deviation?
- How has this experience improved your ability to identify, assess, and respond to unplanned deviations in the future?
- What aspects of deviation management do you feel more confident in now?
- Are there any areas where you would like further guidance?
- What actions will you take to further develop your understanding of quality management systems and deviation handling in radiopharmacy?
- What support or resources could help you further develop your skills in this area?
Beyond action
- Have you reflected on the types of deviations you encountered and how your approach to assessing and resolving them might differ based on your current knowledge and experience?
- Have you reviewed the documentation related to these deviations and considered any long-term impacts or lessons learned by the department?
- Have you discussed these deviations and their resolution with senior colleagues to understand their decision-making processes?
- Did you receive any feedback?
- Consider the similarities and differences in the type of deviations seen in aseptics and radiopharmacy and how these are investigated and documented.
- Has this training activity enhanced your ability to critically appraise procedures and practices in radiopharmacy?
- How has your understanding of pharmaceutical quality management systems improved through dealing with unplanned deviations?
- Has this experience influenced the advice you provide to other healthcare professionals regarding potential issues in radiopharmacy production?
- How might your experience in assessing and resolving deviations prepare you for more senior roles involving quality assurance or management in radiopharmacy?
- Will your understanding of the root causes of deviations and the implementation of corrective actions contribute to your ability to participate in continuous improvement initiatives?
- What clear actions for continued development in the area of deviation management have you identified?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Critically appraise procedures and practices relating to the production and quality assurance of radiopharmaceuticals. |
| # 4 |
Outcome
Explain clinical and radiation protection aspects of radiopharmaceuticals and provide advice to the other healthcare professionals. |
| # 5 |
Outcome
Evaluate and apply pharmaceutical quality management systems. |