Production —
Training activity: 10

Details

Evaluate a range of recent deviation reports and associated CAPAs applied

Type

Entrustable training activity (ETA)

Evidence requirements

Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion. ​

Reflection at multiple timepoints on the trainee learning journey for this activity.

Considerations

• Regulatory and good practice guidance
• Pharmaceutical Quality System.
• Robustness of the investigation and associated CAPA.
• quality risk management
• Change management
• Audit – external and internal

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 does success look like for evaluating deviation reports and CAPAs?
  • Identify what is expected of you in relation to this specific activity by reviewing the specific learning outcomes related to this activity, particularly describing working practices, applying quality risk management, and demonstrating critical awareness of investigating problems.
  • Discuss with your Training Officer to gain clarity on what is expected, including the depth of analysis required, the focus of the evaluation (e.g., root cause analysis, effectiveness of CAPA), and the format for reporting findings.
• What is your prior experience with deviation reports, investigations, or corrective and preventative actions (CAPAs)?
  • Think about what you already know about identifying deviations, understanding root causes, or assessing the impact of non-conformances. Have you observed or participated in any deviation investigations or quality meetings where these were discussed?
  • Consider possible challenges you might face when evaluating deviation reports, such as deciphering incomplete information, identifying systemic issues, determining the effectiveness of CAPAs, or proposing further improvements. Think about how you might handle these potential issues.
  • Recognise the scope of your own practice for this activity. For example, when would you need to seek advice or help regarding complex multi-departmental deviations, significant patient safety implications, or unresolved recurring issues, and from whom would you seek it?
• What do you anticipate you will learn from evaluating these deviation reports and CAPAs?
  • Consider the specific skills you want to develop, drawing upon previous experiences (e.g., improving your critical thinking in problem investigation, enhancing your understanding of quality risk management principles, or refining your ability to propose effective solutions).
  • Identify the specific insights you hope to gain, such as a deeper understanding of common pitfalls in production processes, the effectiveness of different CAPA strategies, or how deviations impact patient safety and product quality.
• What additional considerations do you need to make before evaluating the deviation reports?
  • Consult actions identified following previous experiences related to quality incidents or problem-solving. Have you identified any areas for improvement in your analytical skills or understanding of the quality management system that you need to focus on?
  • Identify important information you need to consider before embarking on the activity, such as the company’s deviation management procedure, criteria for CAPA effectiveness, and any relevant regulatory expectations regarding investigations and quality improvements.

In action

• During the evaluation of the deviation reports and CAPAs, does anything unexpected occur?
  • Make a note of anything that feels surprising or different from what you anticipate while reviewing the reports. This can include:
    • An unclear or incomplete deviation report, making root cause analysis difficult.
    • A CAPA that seems ineffective or not directly addressing the root cause identified.
    • Evidence suggesting a systemic issue rather than an isolated incident, despite the report’s conclusion.
    • New information emerging (e.g., from an attached document) that contradicts the main report’s narrative.
    • A recurring deviation despite previous CAPAs being implemented.
  • Consider how this experience compares with previous experiences of evaluating quality documents or issues. Is this a new challenge in critically assessing documentation, or does it relate to a prior observation?
• How do you react to the unexpected development during the evaluation? Identify how this impacts upon your actions. For example:
  • Do you respond to the situation appropriately? Do you immediately pause your evaluation, re-read relevant sections, or consider what further information might be needed?
  • Do you adapt or change your approach to reviewing the report based on the unexpected finding? Do you re-prioritise certain aspects of your analysis?
  • Does it affect your ability to undertake the activity independently or do you need to immediately consult with your Training Officer for clarification or guidance on the report’s content?
• Consider how you feel in that moment. For example:
  • Do you find it difficult to critically assess the information due to the unexpected elements?
  • Does it affect your confidence in forming a conclusion about the effectiveness of the CAPA?
  • Do you feel positive you can complete a thorough evaluation despite the inconsistencies?
• What is the immediate conclusion or outcome of your reaction to the unexpected development?
  • Identify how you work within your scope of practice to address the unexpected element in the reports. Do you recognise if the issue is beyond your current level of understanding or requires expert input?
  • Identify what you learn as a result of the unexpected development while you are still evaluating. This can be a new technique for identifying discrepancies in reports, a deeper understanding of CAPA effectiveness, or the importance of comprehensive root cause analysis.

On action

• What happened during the evaluation of the deviation reports and CAPAs?
  • Summarise the key points of your evaluation experience, from reviewing the initial reports to assessing CAPA effectiveness.
  • Consider specific events, actions, or interactions that felt important, including your own feelings during the assessment. This could involve identifying a particularly well-documented deviation or a concerning recurrence.
  • Include any ‘reflect-in-action’ moments where you adapted to unexpected findings or made immediate decisions while critically appraising the reports. For example, if you found an unclear root cause, how did you immediately respond and what was the outcome at that moment?
• How has this evaluation experience contributed to your developing practice?
  • Identify what learning you can take from this experience. What strengths did you demonstrate in critically assessing deviation reports, understanding root cause analysis, or evaluating CAPA effectiveness? Were any skills or knowledge gaps evident, such as deeper understanding of specific manufacturing processes or quality risk management principles?
  • Compare this experience against previous engagements with similar quality documentation reviews. Were any previously identified actions for development achieved? Has your practice improved in identifying inconsistencies, evaluating the robustness of investigations, or assessing the impact of deviations on GMP/PQS?
  • Identify any challenges you experienced during the evaluation and how you reacted to these. Did this affect your ability to deal with the situation independently, such as when confronting unclear reports or ineffective CAPAs? Were you able to overcome the challenges, like linking seemingly unrelated deviations to systemic issues?
  • Identify anything significant about the activity. Did you need to seek advice or clarification from your Training Officer or quality personnel, for instance, regarding a particularly complex deviation or the rationale for a CAPA? Did you need to escalate any findings that suggested a significant unaddressed risk or systemic issue?
  • Acknowledge any changes in your own feelings now that you are looking back on the experience. Do you feel more confident in your ability to critically assess quality documentation and contribute to quality improvement?
• What will you take from this evaluation experience moving forward?
  • Identify the actions or ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you received.
  • What will you do differently next time you evaluate deviation reports and CAPAs, especially if faced with similar challenges like incomplete information or recurring issues?
  • Has anything changed in terms of what you would do if you were faced with a similar deviation evaluation situation again?
  • Do you need to practise any aspect of the activity further, such as specific root cause analysis techniques, understanding different types of deviations, or critically appraising the effectiveness of CAPAs?

Beyond action

• Have you revisited your previous experiences with evaluating deviation reports and CAPAs?
  • Have you reviewed your actions from your previous reflections for evaluating deviation reports and CAPAs? What actions did you identify you would need to take to improve your practice in assessing deviations, understanding root cause analysis, or evaluating CAPA effectiveness (e.g., related to identifying recurrence, assessing risk, or proposing robust corrective actions)?
  • Have you completed these identified actions from previous evaluations of deviation reports? Are you ready to demonstrate this new learning in your current and future evaluation practice?
  • Consider if your view of problem investigation (e.g., assessing the thoroughness of root cause analysis, the appropriateness of CAPAs, or the impact on patient safety) has changed because of analysing this with others. Mutual exchange of experiences can lead to transformation in your understanding and approach.
• How have these collective experiences with evaluating deviation reports and CAPAs impacted your current practice?
  • Consider how the learning from repeated evaluations of deviation reports will support you in preparing for observed ‘in-person’ assessments for the module.
  • Consider how your practice in evaluating deviations and CAPAs has developed and evolved over time, including recognising when something related to a deviation or its proposed CAPA is beyond your scope of practice and requires seeking advice or escalation. For instance, recognising when a deviation might indicate a systemic issue requiring higher-level intervention.

Relevant learning outcomes

#	Outcome
# 1	Outcome Describe the working practices of pharmaceutical production.
# 3	Outcome Perform a range of manufacturing activities, using specialist equipment, in accordance with requirements for GMP and pharmaceutical quality management systems.
# 6	Outcome Apply the principles of quality risk management to the manufacturing process.