Training activity information
Details
Write a deviation report of an equipment failure and carry out an investigation into this failure
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
- Examples of equipment failures might include:
- Leak test failure
- Failure of sessional isolator checks
- Fridge out of temperature range
- AHU failure
- National guidance and local SOPs
- Documentation of deviation
- Investigation of deviation
- Root cause analysis – methods and outcome
- Appropriate corrective actions
- Change control
- Risk assessment
- Impact assessment
- Prioritisation of actions
- Limits of practice
- Appropriate escalation
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 key elements that should be included in a deviation report?
- What steps are typically involved in investigating an equipment failure in an aseptic unit?
- What is the goal of the investigation (e.g., identify root cause, implement corrective and preventative actions)?
- What is the departmental SOP for raising and managing deviations? Where can you access the relevant forms and guidelines?
- What is the process for reporting equipment failures in the aseptic unit? Who needs to be informed?
- What information is typically required to initiate an investigation into an equipment failure (e.g., details of the failure, time, impact)?
- What tools or techniques might be used during the investigation to identify the root cause (e.g., Ishikawa diagram, 5 Whys)?
- Who are the individuals within the department with expertise in equipment maintenance and troubleshooting?
- Have you reviewed examples of previous deviation reports and investigation reports within your department?
- Do you need to refresh your knowledge on root cause analysis techniques?
- What information do you need to gather about the equipment that failed (e.g., maintenance history, operating procedures)?
In action
- How are you approaching the writing of the deviation report?
- What information are you prioritising?
- How are you structuring the report?
- During the investigation, what steps are you taking to gather information? What questions are you asking?
- What decisions are you making as you document the failure and investigate its cause?
- Are you deciding which details are crucial for the report? Are you determining the scope of the investigation?
- How effective are your actions in accurately documenting the deviation and conducting a thorough investigation?
- Are you capturing all the necessary details in the report?
- Are you making progress in identifying the cause of the failure?
- What challenges are you facing during this activity?
- Are there any difficulties in obtaining information about the failure? Are there conflicting accounts?
- Are you gaining a better understanding of equipment operation, potential failure points, or the deviation reporting process?
- Are you applying knowledge of quality management systems or risk assessment during the investigation?
- Are there alternative approaches you could be considering for the investigation?
- Could you use different problem-solving techniques?
- Should you involve other colleagues? Do you need input from engineering or other departments?
- Do you need clarification on reporting procedures?
- Are you working within the local guidelines for deviation reporting and investigation?
On action
- What was the nature of the equipment failure you investigated?
- What information did you include in the deviation report?
- What steps did you take to investigate the cause of the equipment failure?
- What data or evidence did you gather during your investigation?
- Were there any immediate actions taken to mitigate the impact of the failure?
- What did you learn about the process for reporting and investigating equipment failures in an aseptic unit?
- How did this activity enhance your understanding of potential equipment vulnerabilities and their impact on aseptic processes?
- What insights did you gain into the importance of thorough investigation and root cause analysis?
- How did this experience relate to risk management in the aseptic environment?
- Did you learn about any specific procedures or protocols related to the failed equipment?
- How will you approach future equipment failures or deviations based on this experience?
- What key considerations will you keep in mind when writing deviation reports and conducting investigations?
- What actions or ‘next steps’ were identified as a result of your investigation (e.g., corrective and preventative actions)?
- Do you need further training or resources on equipment failure investigation or deviation management?
Beyond action
- Have you been involved in other deviation investigations since this training activity? How did your approach compare to your initial investigation?
- Have you reviewed your original deviation report and the outcomes of the investigation? What did you learn in retrospect?
- Have you compared this equipment failure with other incidents or deviations within the aseptic unit? What common themes or differences did you observe?
- Have you discussed the investigation process with more experienced colleagues? Did their insights highlight any areas for improvement in your approach?
- Are you now more confident in identifying and documenting deviations from normal operating procedures? Has your understanding of root cause analysis and the importance of thorough investigation improved?
- How has this experience influenced your awareness of potential risks and vulnerabilities within the aseptic unit? Has your ability to contribute to corrective and preventative actions (CAPA) been enhanced by this activity?
- How will your experience in deviation management and investigation support your future roles in quality assurance, risk management, or training within the aseptic service?
- What further development in areas such as quality management systems, regulatory requirements for deviation reporting, or advanced investigation techniques might be beneficial?
- How can you apply the principles of thorough investigation and root cause analysis to other aspects of your professional practice?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Interpret monitoring results and trends and take appropriate action to correct out of specification results. |
| # 4 |
Outcome
Critically evaluate the design, installation and PPM of an aseptic unit and LAFCs/Isolators. |
| # 6 |
Outcome
Apply risk management techniques in the context of aseptic medicines. |