Training activity information
Details
Investigate a questionable laboratory result or out of trend result
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
- Procedure
- Analyst self-check
- Supervisor check
- Hypothesis testing
- Repeat testing
- Resampling
- Notifying customers
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 investigating a questionable or out-of-trend laboratory result?
- Identify what is expected of you in relation to this specific activity. Success involves systematically following quality system requirements, effectively liaising with relevant personnel (analysts, supervisors, customers), and demonstrating a critical awareness of the investigation process, including equipment calibration, IQC/EQA, out of specification and out of trend data.
- Consider how a thorough investigation contributes to ensuring product quality and patient safety, which is the overall aim of the module.
- Discuss with your training officer to gain clarity on the expected depth of investigation, reporting requirements, and communication protocols for different types of questionable results.
- What is your prior experience with investigating questionable or out-of-trend laboratory results?
- Think about what you already know about problem investigation during manufacturing. Have you been involved in or observed such investigations before? What was the typical process followed?
- Consider possible challenges you might face, such as identifying the root cause, collecting all necessary data, dealing with incomplete information, or communicating sensitive findings. Think about how you might handle these challenges.
- Recognise the scope of your own practice for this activity, i.e., knowing when you will need to seek advice or help (e.g., from a quality assurance professional or a subject matter expert) and from whom, especially if the issue is complex or has significant implications.
- Acknowledge how you feel about embarking on this training activity. Do you feel confident in your analytical and problem-solving skills for this type of investigation?
- What do you anticipate you will learn from investigating this activity?
- Consider the specific skills you want to develop, drawing upon previous experiences with quality systems or data analysis. For example, do you want to enhance your root cause analysis skills, improve your ability to gather evidence, or refine your communication skills when presenting findings?
- Identify the specific insights you hope to gain from engaging with the activity, such as a deeper understanding of how robust investigation processes prevent recurrence and ensure data integrity.
- What additional considerations do you need to make before undertaking this activity?
- Consult actions identified following previous experiences with quality issues or data analysis. Did you identify any areas for improvement in your previous reflections that are relevant here?
- Identify important information you need to consider before embarking on the activity, such as reviewing the company’s deviation investigation procedures, understanding the different types of potential laboratory errors or trends, and familiarising yourself with principles of data integrity.
In action
- During the investigation, does anything unexpected occur?
- Make a note of anything that feels surprising or different from what you anticipate during the investigation process. This can include conflicting information, an unexpected root cause, or a difficulty in gaining necessary data or input (e.g., from equipment calibration records or IQC/EQA).
- Consider how this experience compares with previous experiences of similar investigations or problem-solving scenarios. Is this deviation more complex or straightforward than others?
- How do you react to the unexpected development?
- Identify how the unexpected development impacts upon your actions. For instance, do you change your investigative approach, decide to involve additional personnel, or alter your communication strategy (e.g., when explaining a questionable result to a customer or feeding back an investigation outcome to an analyst)? Does it affect your ability to undertake the activity independently?
- Consider how you feel in that moment. Do you find it difficult to adapt to the unfolding information? Does it affect your confidence in leading the investigation? Do you feel positive you can reach a successful conclusion?
- What is the conclusion or outcome?
- Identify how you work within your scope of practice when managing the unexpected. Do you recognise when the issue is beyond your authority, or when to escalate the investigation to a supervisor or quality assurance?
- Identify what you learn as a result of the unexpected development. For example, do you discover a new source of information, a more effective communication method, or a specific type of root cause you haven’t considered before?
On action
- What happened during the investigation of the questionable or out-of-trend result?
- Summarise the key events and findings of the investigation you conducted. What was the initial questionable or out-of-trend result? What steps did you follow in your investigation?
- Detail any unexpected developments or conflicting information that arose during the investigation, such as difficulties in gaining necessary data or input (e.g., from equipment calibration records or IQC/EQA).
- Describe your actions and reactions to these unexpected developments. Did your investigative approach change? Did you involve additional personnel or alter your communication strategy?
- How has this experience contributed to your developing practice in laboratory investigations?
- What specific learning can you take from leading this investigation? What strengths did you demonstrate in applying quality system requirements or in liaising with analysts, supervisors, and customers?
- Were any skills or knowledge gaps evident, particularly in root cause analysis, data interpretation, or effective communication of findings?
- How did this investigation compare to previous problem-solving or investigation scenarios you have engaged with? Did your ability to conduct independent investigations improve?
- How did you work within your scope of practice when managing unexpected information or issues during the investigation? Did you recognise when the issue was beyond your authority or when to escalate to a supervisor or quality assurance?
- Reflect on your feelings during and after the investigation. Did difficulties adapting to unfolding information affect your confidence in leading the investigation?
- What will you take from this investigation experience moving forward?
- What specific actions or next steps will you take to improve your ability to investigate questionable or out-of-trend results? This could include refining your investigative protocols, improving your communication skills, or seeking further training on specific types of root causes.
- Has anything changed in terms of how you would approach a similar investigation in the future, particularly regarding data integrity, second checks, or reporting outcomes?
- How will this experience inform your critical awareness of the process for investigating questionable laboratory results, out of specification and out of trend data?
Beyond action
- Have you revisited your experiences with investigating questionable or out-of-trend results?
- Have you reviewed your past reflections on investigating questionable or out-of-trend laboratory results? What actions did you commit to in terms of improving your root cause analysis, your communication skills, or your application of relevant quality system requirements? Have you successfully implemented these actions in subsequent investigations, and are you now more proficient at leading such investigations independently while adhering to data integrity principles?
- Have you engaged in professional storytelling with peers, supervisors, or quality assurance personnel about specific challenging investigations you have conducted? Has this external perspective refined your understanding of critical steps in the investigation process, the importance of second checks, or the most effective ways to communicate findings and liaise with stakeholders?
- How have these cumulative investigation experiences impacted your current practice?
- How does your developed ability to investigate questionable laboratory results, critically evaluate data, and communicate outcomes contribute to your readiness for observed ‘in-person’ assessments?
- How has your practice in conducting laboratory investigations developed and evolved over time? Are you now more skilled at applying quality system requirements, understanding the role of equipment calibration or IQC/EQA, and knowing when to escalate an issue or seek advice from a supervisor or quality assurance?
- How has your critical awareness of the entire process for investigating questionable laboratory results, out of specification and out of trend data, improved?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 |
Outcome
Perform a range of chemical analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| # 2 |
Outcome
Perform a range of microbiological analytical techniques that provide evidence of product quality to ensure that samples meet the agreed specifications; analysing, interpreting, reporting and acting on the results. |
| # 3 |
Outcome
Apply physical and environmental monitoring tests to provide evidence of facility compliance and ascertain compliance with requirements. |
| # 4 |
Outcome
Write specifications for routine quality control and stability assessment based on relevant standards and guidance. |
| # 5 |
Outcome
Investigate questionable laboratory results or out of trend results following quality system requirements, liaising with analysts, supervisor and customers where appropriate. |
| # 7 |
Outcome
Describe the requirements of data integrity related to quality control systems. |