Overview
Question 1 50%
Scenario:
You are a quality control manager in a pharmaceutical manufacturing facility. The company has recently expanded its production line to include a new category of medications. Given the critical nature of pharmaceutical products and their direct impact on public health, you need to conduct a comprehensive risk assessment using the matrix method to identify, evaluate, and manage potential risks in the new production processes.
Project Management (MECH 0015.1) – Spring-2025 – CW1 (Assignment 1) – Session A – QP
MEC_AMO_TEM_035_04 Page 2 of 12
Task:
Identify the types of pharmaceutical products being manufactured and conduct a detailed risk assessment using the matrix method for a selected set of operations within the new production line. You must identify potential hazards, evaluate their probability and impact, determine the overall risk rating for each hazard, prioritize these hazards based on their risk ratings, and provide recommendations for risk control.
Instructions:
I. Select at least five critical operations from the pharmaceutical manufacturing process that require risk assessment.
II. Identify and document the hazards associated with each selected operation.
III. Create a risk matrix with appropriate probability and impact levels. You may use a 5×5 matrix or modify it as needed.
IV. Evaluate the probability and impact of each hazard and assign corresponding values from the risk matrix.
V. Calculate the overall risk rating for each hazard (probability × impact).
VI. Prioritize the hazards based on their risk ratings, ordering them from highest to lowest risk.
VII. For the top three high-risk hazards, develop comprehensive recommendations on how to effectively control or mitigate these risks.
Submission Guidelines:
Tasks and mark distribution:
I. Introduction to the pharmaceutical manufacturing facility and the importance of risk assessment in pharmaceutical production. (5 marks)
II. List of selected operations and their associated hazards. (5 marks)
III. Developed risk matrix with probability and impact levels. (10 marks)
IV. Hazard evaluations, risk ratings, and justifications. (10 marks)
V. Prioritized list of hazards with calculated risk ratings. (5 marks)
VI. Detailed recommendations for mitigating the top three high-risk hazards. (10 marks)
VII. Conclusion emphasizing the importance of risk assessment in ensuring product quality, patient safety, and regulatory compliance. (5 marks)
Total: (50 Marks)
Question 2 30%In the field of advanced manufacturing, project success hinges on effective collaboration among diverse specialists. Consider the development of next-generation renewable energy systems—a complex engineering challenge requiring multidisciplinary expertise and coordinated team efforts.
(a) For a comprehensive renewable energy system development project, identify the critical professionals needed on the team and their specific roles. (15 marks)
(b) Develop criteria for selecting project managers and structuring job responsibilities for new project managers. (15 marks)
Give appropriate reference and citation for your answer.
Limit your discussion between 300 and 400 words.
Question 3 20%
Project: Airport Terminal Construction with Specialized Equipment Installation:
A project manager is overseeing the construction of a new international airport terminal with contractual penalties for delayed completion. The manager must select a subcontractor for specialized baggage handling system installation, which is on the critical path. The selection must balance costs against delivery timelines to meet project deadlines and minimize financial penalties.
(a) Subcontractor Selection Analysis:
Sub-contractor X bids 3,750,000 USD. There is a 40% probability of completing the installation 35 days late. According to the contract with the airport authority, a delay penalty of 7,800 USD must be paid per calendar day for any late delivery.
Sub-contractor Y bids 4,200,000 USD. There is a 15% probability of completing the installation 12 days late. The same delay penalty of 7,800 USD per calendar day applies.
Determine which sub-contractor is appropriate for this critical path activity. Both sub-contractors guarantee successful implementation and high-quality installation.
(b) In outlining the work plan in your final year project (FYP), analyze and compare the suitability of Critical Path Method (CPM) and Program Evaluation and Review Technique (PERT) as project management techniques. Provide your justifications for the preferred choice. Limit your discussion to between 150 and 200 words. (10 marks)
Project Team Dynamics in Complex Engineering Projects: