Production —
Training activity: 5

Details

Complete the supplier approval process for the following:

• A starting material
• A packaging component

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

• Supply chain criticality
• Impact on patient safety and product quality
• Regulatory and good practice guidance
• On-going testing requirements
• Communication with other departments/stakeholders

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 completing the supplier approval process?
  • Identify what is expected of you in relation to this specific activity by reviewing the specific learning outcomes related to this activity, particularly applying principles of supplier approval and quality assessment for starting materials and packaging components and incorporating quality risk management.
  • Discuss with your Training Officer to gain clarity on what is expected, including the specific documentation required, the criteria for approval, and the role of quality risk management in the process.
• What is your prior experience with supplier approval processes or quality assessments of materials?
  • Think about what you already know about evaluating suppliers, reviewing material specifications, or assessing compliance documentation.
  • Have you observed or participated in any part of this process before?
  • Consider possible challenges you might face during the supplier approval process, such as interpreting complex technical data, identifying non-conformities, handling discrepancies in documentation, or assessing a supplier’s quality management system. 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 supplier audits, critical non-conformances, or significant regulatory issues, and from whom would you seek it?
• What do you anticipate you will learn from completing the supplier approval process?
  • Consider the specific skills you want to develop, drawing upon previous experiences (e.g., improving your ability to critically appraise supplier documentation, understanding the nuances of material specifications, or conducting effective risk assessments).
  • Identify the specific insights you hope to gain, such as a deeper understanding of how supplier approval directly impacts product quality and patient safety, or the practical application of quality risk management in preventing supply chain issues.
• What additional considerations do you need to make before engaging in the supplier approval process?
  • Consult actions identified following previous experiences related to quality assessment or supply chain management.
  • Have you identified any areas for improvement in your critical appraisal skills or understanding of regulatory requirements that you need to focus on?
  • Identify important information you need to consider before embarking on the activity, such as relevant regulatory guidelines (e.g., GMP, GDP), company Standard Operating Procedures (SOPs) for supplier approval, and any specific requirements for the starting material or packaging component in question.

In action

• During the supplier approval process, does anything unexpected occur?
  • Make a note of anything that feels surprising or different from what you anticipate during the approval of the starting material or packaging component. This can include:
    • An inconsistency or missing information in supplier documentation (e.g., Certificates of Analysis, audit reports, quality questionnaires)
    • An unexpected finding during a virtual or on-site supplier assessment
    • Conflicting information from different sources about the supplier’s quality system or material specifications
    • A significant quality risk identified that is not initially apparent or expected
    • A deviation from your employer’s internal supplier approval
  • Consider how this experience compares with previous experiences of similar quality assessment activities. Is this a new challenge in evaluating supplier data, or does it relate to a previous observation?
• How do you react to the unexpected development during the supplier approval process?
  • Identify how this impacts upon your actions. For example:
    • Do you respond to the situation appropriately? Do you immediately pause your assessment, request clarification from the supplier, or consult with a quality manager?
    • Do you adapt or change your approach to evaluating the supplier or material based on the unexpected information? How quickly do you adjust your focus?
    • Does it affect your ability to undertake the activity independently or do you need to immediately seek support or guidance from your Training Officer?
  • Consider how you feel in that moment. For example:
    • Do you find it difficult to adapt to the unexpected information or challenge?
    • Does it affect your confidence in making a recommendation for approval or rejection?
    • Do you feel positive you can reach a successful conclusion despite the unexpected issue?
• 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 event during the approval process.
  • Do you recognise the need for further investigation or escalation before proceeding?
  • Identify what you learn as a result of the unexpected development while it is unfolding. This can be a new critical appraisal skill, an insight into common supplier issues, or the practical application of risk assessment criteria.

On action

• What happened during the supplier approval process?
  • Summarise the key points of the supplier approval experience, from reviewing documentation to making recommendations.
  • Consider specific events, actions, or interactions that felt important, including your own feelings during the assessment. This could include critical discrepancies you identified or crucial discussions held.
  • Include any ‘reflect-in-action’ moments where you adapted to unexpected information or made immediate decisions while evaluating the supplier or material. For example, if you identified a missing piece of documentation, how did you immediately respond and what was the outcome at that moment?
• How has this supplier approval experience contributed to your developing practice?
  • Identify what learning you can take from this experience. What strengths did you demonstrate in applying principles of supplier approval, quality assessment, and quality risk management?
  • Were any skills or knowledge gaps evident, such as understanding specific quality standards or interpreting audit reports?
  • Compare this experience against previous engagements with similar quality assessment activities. Were any previously identified actions for development achieved?
  • Has your practice improved in critically appraising supplier data or identifying potential risks?
  • Identify any challenges you experienced during the approval process and how you reacted to these. Did this affect your ability to deal with the situation independently, such as when conflicting information arose?
  • Were you able to overcome the challenges, like incomplete documentation or ambiguous supplier responses?
  • Identify anything significant about the activity. Did you need to seek advice or clarification from your Training Officer or quality team, for instance, regarding the interpretation of a regulatory requirement or a risk assessment outcome? Did you need to escalate any concern to ensure you were working within your scope of practice?
  • 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 conduct supplier evaluations or identify quality risks?
• What will you take from this supplier approval 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 conduct a supplier approval, especially if faced with similar challenges like data inconsistencies or unaddressed risks?
  • Has anything changed in terms of what you would do if you were faced with a similar supplier approval situation again?
  • Do you need to practise any aspect of the activity further, such as critical document review, risk assessment techniques, or communication with suppliers?

Beyond action

• Have you revisited your previous supplier approval experiences?
  • Have you reviewed your actions from your previous reflections for completing supplier approval processes?
  • What actions did you identify you would need to take to improve your practice in evaluating suppliers, starting materials, or packaging components (e.g., related to critical appraisal of documentation, risk assessment, or understanding regulatory expectations)?
  • Have you completed these identified actions from previous supplier approval experiences? Are you ready to demonstrate this new learning in your current and future supplier approval practice?
  • Consider if your view of supplier evaluation situations (e.g., dealing with incomplete documentation, assessing supplier reliability, or identifying critical quality risks) has changed because of analysing this with others.
• How have these collective supplier approval experiences impacted your current practice?
  • Consider how the learning from repeated supplier approval activities will support you in preparing for observed ‘in-person’ assessments for the module.
  • Consider how your practice in completing supplier approval processes has developed and evolved over time, including recognising when something related to supplier quality or material assessment is beyond your scope of practice and requires seeking advice or escalation.

Relevant learning outcomes

#	Outcome
# 4	Outcome Apply the principles of supplier approval and quality assessment to evaluate a range of starting materials and packaging components.
# 6	Outcome Apply the principles of quality risk management to the manufacturing process.