Solid Cancers 2 —
Training activity: 14

Details

Perform and document an audit, make recommendations and agree actions

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

• Audits types
• Audit purpose
• Audit schedules and cycles
• Communication of outcomes

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?

• Identify what is expected of you in relation to performing and documenting an audit, making recommendations, and agreeing actions.
• Consider how the learning outcomes apply, specifically in relation to Interpreting QC data including EQA and ISO:15189 standards.
• Discuss with your training officer to gain clarity of what is expected of you in relation to expectations for audit scope, methodology, and formulating clear recommendations.

What is your prior experience of this activity?

• Think about what you already know about audit principles, methodologies, and documentation requirements.
• Consider possible challenges you might face during the activity, such as planning an audit, collecting data, identifying non-conformances, or formulating effective recommendations, and think about how you might handle them.
• Recognise the scope of your own practice for this activity i.e. know when you will need to seek advice or help, and from whom. You will need to seek advice from your Training Officer when required, for example when selecting an audit topic or methodology that impacts a politically sensitive or under-resourced area of the laboratory.
• Acknowledge how you feel about performing an audit.

What do you anticipate you will learn from the experience?

• Consider the specific skills you want to develop, such as conducting audits effectively, documenting findings, and proposing meaningful recommendations for improvement.
• Identify the specific insights you hope to gain into how audits contribute to maintaining and improving quality standards in the laboratory.

What additional considerations do you need to make?

• Consult actions identified following previous experiences of quality processes or audits.
• Identify important information you need to consider before embarking on the activity, such as the specific process or area being audited, relevant procedures or standards (e.g., ISO:15189), and how to agree actions with relevant personnel.

In action

Is anything unexpected occurring?

• Are you noticing anything surprising or different from what you anticipate whilst performing an audit and formulating findings?
• Are you encountering situations such as:
  • A process deviation you did not foresee when comparing practice against the written procedure?
  • Difficulty interpreting a quality standard against laboratory practice in real-time during the observation phase?
  • Unexpected resistance to potential recommendations from staff members being audited?

How are you reacting to the unexpected development?

• How is this impacting your actions? For example, are you responding to the situation appropriately? Did you need to adjust your audit questions or approach on the spot?
• Consider the steps you are taking in the moment, such as immediately documenting the deviation neutrally to ensure factual accuracy or pausing the interview process to seek clarification on the specific quality standard being applied.
• How are you feeling in that moment? For instance, did this affect your confidence in conducting the audit or proposing actions independently? Are you finding it difficult to manage the interpersonal dynamics of the audit process?

What is the conclusion or outcome?

• Identify how you are working within your scope of practice. For example, are you successfully documenting a process deviation factually despite unexpected resistance? Or are you needing support because the unexpected process deviation impacts patient safety and requires immediate, senior escalation?
• What are you learning as a result of the unexpected development? For example, are you gaining insight about the auditing process, such as the importance of pre-auditing the written SOP before starting the physical observation?

On action

What happened?

• Begin by summarising the key steps you took when performing and documenting the audit, including the specific process or area audited and the methodology used.
• Consider specific events, actions, or interactions which felt important, such as how you gathered objective evidence, or how you communicated findings and sought consensus on corrective actions with the audited staff.
• Include any ‘reflect-in-action’ moments where you had to adapt to the situation as it unfolded, for instance, immediately adjusting the tone of your questioning when encountering unexpected staff resistance to the audit process, to maintain professionalism and objectivity.
• How did you feel during this experience, e.g., did you feel confident in applying audit standards or challenged by the interpersonal dynamics of documenting a non-conformance?

How has this experience contributed to your developing practice?

• Identify what learning you can take from this experience regarding audit performance. What strengths did you demonstrate, e.g., objective documentation of process adherence and systematic collection of audit evidence?
• What skills and/or knowledge gaps were evident, e.g., difficulty in formulating recommendations that were perceived as achievable by the operational team?
• Compare this experience against previous engagement with similar activities – were any previously identified actions for development achieved? Has your practice improved in achieving consensus on corrective actions?
• Identify any challenges you experienced, such as needing to seek advice or clarification on scope of practice regarding the appropriate escalation of a major process deviation that impacted patient safety, and how you reacted to this.

What will you take from the 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 have received, with regards to improving your audit documentation and stakeholder engagement.
• What will you do differently next time you approach performing an audit, for instance, by proactively reviewing the communication guidelines for delivering potentially critical feedback to audited staff?
• Do you need to practise any aspect of the activity further, such as reviewing root cause analysis techniques or key learning outcomes related to quality management systems and internal auditing?

Beyond action

Have you revisited the experiences?

• How have your subsequent experiences of performing audits since completing this specific training activity led you to revisit your initial approach or decisions during that activity? For example, how a subsequent audit revealed recurring staff resistance to recommendations forced you to re-evaluate the clarity and achievability of your initial recommendations and action planning you applied during your first attempt at this training activity?
• Considering what you understand about audit methodology, documentation, and quality standards now, were the actions or considerations you identified after your initial reflection on this training activity sufficient? How have you since implemented or adapted improvements in your audit technique and recommendation formulation based on further learning and experiences? For example, how you proactively reviewed and integrated guidelines for presenting findings to increase staff buy-in for corrective actions?
• Has discussing challenging audit scenarios involving conflict over process adherence or the value of audit in maintaining ISO:15189 standards with colleagues, peers, or supervisors changed how you now view your initial experience in this training activity? For example, how professional storytelling with a senior quality manager about a time when a recommendation failed to address the true root cause of a deviation refined your understanding of the critical nature of effective root cause analysis in auditing?

How have these experiences impacted upon current practice?

• How has the learning from this initial training activity, in combination with subsequent experiences, contributed to your overall confidence and competence in auditing and quality management, particularly in preparing for assessments where you discuss quality processes? For example, how your accumulated ability in performing and documenting audits now enables you to confidently discuss the audit process and its contribution to quality standards?
• How has reflecting back on this specific training activity, combined with everything you’ve learned since, shaped your current approach to internal auditing? How does this evolved understanding help you identify when something is beyond your scope of practice or requires escalation? For example, how your evolved approach means you now routinely seek advice immediately when a major process deviation impacting patient safety is identified that requires immediate senior management intervention?
• Looking holistically at your training journey, how has this initial experience, revisited with your current perspective, contributed to your development in interpreting QC data including EQA and ISO:15189?

Relevant learning outcomes

#	Outcome
# 4	Outcome Interpret QC data including bioinformatic and NGS quality metrics in relation to assay performance, EQA and ISO:15189 standards.