A Major Pharmaceutical Company Manufactures Products - Management Assignment Help

Assignment Task:

Task:

Background:
A major pharmaceutical company manufactures products on a commercial scale including Oral Solid Dosage forms, liquid suspensions and encapsulated products.
Choose scenario (a) OR (b)
A batch of a leading OSD product (batch #345-9) for the treatment of stomach ulcers was found to be contaminated with small black particles after the blending stage of manufacture upon QC analysis.
Customer complaints reported clear crystalline particles in an oral liquid suspension for the treatment of pain relief.
Tasks:

• Using scenario (a) or (b):
• Prepare a risk question/ problem statement to address the risk scenario (5%)
• Prepare a cause and effect/ fishbone diagram to investigate and identify as many potential failure modes (30%)
• Perform a risk assessment using a FMEA chart (50%)
• Construct FMEA chart
• Using a RPN 1-5 scale, define the RPN ratingsAssign the severity (S), occurrence (O) and detection (D) of 3 identified failure modes from fishbone diagram and calculate total RPNExplain the reason for the assigned RPN rating for each failure mode What action items from the FMEA chart need to be taken to risk mitigate the problem (15%)
• Total word count : 1500-2000
• 4-5 pages with charts/ diagrams

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