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A university is considering expanding its laboratory activity to allow it to undertake commercial work. Due to the precision needed in the pharmaceutical industry, there is the requirement for some new equipment as well accreditation to ISO/IEC 17025:2017. Training costs and consultancy needed would amount to £4500 and accreditation assessment would be likely to be £5800.A dedicated laboratory technician is expected to be needed (salary £22,000). One of the vital pieces of equipment would be a high precision micro balance. Such an instrument would allow very small samples to be weighed accurately.     Question 1 (30 marks)   a)     Consider the likely business case for a project such as this. What would be the key elements within the business case that would have to be considered?       [15 marks]   b)     As part of the initial project planning there would have been the need to consider the stakeholders involved in the project as a whole. Using techniques to analyse the stakeholders, critically analyse the importance of understanding the relevance of stakeholder groups and their interests.       [15 marks]​

User Miguelfg
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a) **Key Elements within the Business Case:**

1. **Cost-Benefit Analysis:** Assess the total costs involved, including equipment, training, consultancy, accreditation, and salary, against the potential financial gains from commercial work. Consider the return on investment (ROI) over time.

2. **Accreditation and Compliance:** Evaluate the necessity and benefits of obtaining ISO/IEC 17025:2017 accreditation. Compliance with industry standards enhances credibility and opens up commercial opportunities.

3. **Equipment Acquisition:** Assess the necessity and cost-effectiveness of acquiring high precision micro balance. Determine how it aligns with the laboratory's goals and potential commercial projects.

4. **Laboratory Technician:** Consider the role of the dedicated technician and their impact on operational efficiency. Evaluate the salary against the benefits brought to the laboratory.

5. **Market Analysis:** Investigate the demand for commercial work in the pharmaceutical industry. Analyze potential clients, competitors, and the market landscape to ensure a viable business opportunity.

6. **Risk Assessment:** Identify potential risks such as uncertainties in commercial contracts, changes in industry regulations, or unforeseen challenges in obtaining accreditation. Develop strategies to mitigate these risks.

7. **Project Timeline:** Develop a realistic timeline for the project, considering equipment procurement, accreditation processes, training, and project initiation.

8. **Financial Viability:** Ensure the financial sustainability of the project by estimating future revenue streams and determining the break-even point.

b) **Stakeholder Analysis:**

1. **Laboratory Staff:** Engage with the laboratory team to ensure their understanding and commitment to the project. Address concerns and involve them in decision-making processes.

2. **Pharmaceutical Industry Representatives:** Identify potential clients and collaborators. Understand their expectations and requirements to tailor laboratory services accordingly.

3. **Accreditation Agencies:** Establish a positive relationship with accreditation bodies. Understand their criteria and expectations for ISO/IEC 17025:2017 compliance.

4. **Training and Consultancy Providers:** Collaborate with training and consultancy services to ensure a smooth integration of new equipment and accreditation processes. Consider their interests in the success of the project.

5. **University Administration:** Communicate with university administrators to gain support for the project. Address any institutional policies or requirements.

6. **Government Regulatory Bodies:** Ensure compliance with pharmaceutical industry regulations and seek approval from regulatory bodies. Understand their expectations and update stakeholders accordingly.

Understanding stakeholder interests is crucial for effective communication, risk management, and project success. By analyzing and addressing the concerns of different stakeholder groups, the laboratory can build support and enhance the likelihood of successful project outcomes.
User Derin
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