BTF3373 QUALITY MANAGEMENT SYSTEM
PROJECT (30%)
Risk Analysis in Pharmaceutical Tablet Manufacturing
You have been hired as a risk management consulting team for Pharmaceutica, which
produces anti-inflammatory tablets. Due to recent industry concerns about product
quality, your task is to conduct a comprehensive risk analysis for the tablet
manufacturing process. Your team will identify and assess risks, prioritize them, and
propose mitigation strategies using key risk management tools. This project will
evaluate your analytical skills, teamwork, and project management.
Additional Requirements
Submission date: End of Week 14
Pages required: Maximum of 10 pages (excluding references and appendices)
References: Include all citations and references (within 5 years)
Plagiarism check: Check for plagiarism and AI-generated content on Turnitin;
similarity must be less than 20% (must be submitted together with the report)
Rubric: Submit together with the rubric
Tasks Submission Submission Date Signature
Task 1: Project Kickoff and Planning Week 6
Task 2: Understanding the Week 8
Manufacturing Process
Task 3: Risk Identification Week 10
Task 4: Risk Assessment and Week 12
Mitigation Planning
Task 5: Report Consolidation and Week 13
Review
Task 6: Final Report Submission Week 14
1
1. Form teams and assign roles:
Task 1: Project Kickoff • Project Lead
and Planning • Risk Assessor
• Research Specialist
• Documentation Specialist
Deliverable: Submit the initial Project Plan which
includes:
• Project outline.
• Role assignments and responsibilities.
• A timeline for tasks and deliverables.
1. Analyze each stage of Pharmaceutica’s manufacturing
Task 2: Understanding process:
the Manufacturing • Raw Material Sourcing
Process • Weighing and Blending
• Granulation and Drying
• Tablet Compression
• Coating and Packaging
2. Identify potential risk points at each stage.
Deliverable: Submit a brief report summarizing the
manufacturing process and highlighting initial risk points
for each stage.
1. Conduct a detailed risk identification for each
Task 3: Risk Identification manufacturing stage, utilizing the following tools:
• FMEA (Failure Modes and Effects Analysis):
Identify possible failure modes, assign initial
severity, occurrence, and detectability ratings, and
calculate Risk Priority Numbers (RPNs).
• Fault Tree Analysis (FTA): Map potential root
causes for key risks, such as contamination or
equipment failure.
• Fishbone Diagram: Categorize causes of major
risks under broad headings like Methods,
Materials, Machinery, Manpower, Environment,
and Measurement.
Deliverable: Submit a preliminary report of identified
risks, including FMEA tables, fault trees, and fishbone
diagrams.
2
1. Risk Prioritization: Refine the RPN values based on
Task 4: Risk Assessment SWIFT (Structured What-If Technique) analysis, adjusting
and Mitigation Planning ratings for severity, occurrence, and detectability.
• SWIFT Analysis: Brainstorm “what-if” scenarios to
identify and document any additional overlooked
risks.
2. Risk Mitigation Plan: Develop and justify strategies to
mitigate the highest-priority risks. Suggested strategies
may include:
• Routine equipment maintenance
• Supplier quality audits
• Enhanced operator training
• Environmental controls and packaging checks
Deliverable: Submit a report with finalized FMEA tables,
updated FTA and Fishbone diagrams, SWIFT analysis
summary, and a detailed mitigation plan.
1. Compile all previous sections into a draft of the final
Task 5: Report report, including:
Consolidation and Review • Process overview
• Risk identification with FMEA tables, FTA, and
Fishbone diagrams
• Risk assessment and mitigation plan
• A reflection on team roles, project challenges, and
management.
Deliverable: Submit the draft for feedback to allow time
for any necessary revisions.
1. Make final edits to the report based on instructor
Task 6: Final Report feedback from Week 13, ensuring all content is clear,
Submission organized, and complete.
Deliverable: Submit the final report, including:
• Process description
• Comprehensive risk analysis with updated
diagrams
• Risk prioritization and mitigation strategies
• Reflective section on project management and
teamwork.
3
RUBRIC
GROUP NO:
MATRIC NO:
Needs Improvement
Criteria Excellent (5) Good (4) Satisfactory (3) Inadequate (1) Weightage Marks
(2)
Project objectives are Project objectives are Project objectives Project objectives are
Project objectives are
clearly defined, thoroughly well-defined and align are generally clear, vaguely defined, with
Project Overview missing or lack clarity 2
understood, and align with deliverables, with but some areas lack unclear alignment to
in defining tasks.
perfectly with deliverables. minor omissions. specificity. tasks.
All team roles are clearly
Team roles are defined Team roles are Team roles are
defined, assigned No clear roles are
Team Roles & and assigned assigned, but there assigned but lack
effectively, and well- defined, leading to 2
Responsibilities appropriately, with is some overlap or clarity or show poor
coordinated for optimal disorganized efforts.
good coordination. ambiguity. coordination.
project flow.
Comprehensive timeline Timeline includes well- Timeline is clear with Limited timeline and No timeline or
with detailed milestones, defined milestones, milestones, but milestones, with milestones established,
Timeline and Milestones 1
all tasks completed ahead with most tasks some tasks may not frequent missed resulting in significant
of schedule. completed on time. meet deadlines. deadlines. delays.
Thorough identification of Major risks identified Risks identified with Limited risk Minimal risk
risks with detailed FMEA, with effective use of partial use of FMEA identification and basic identification, with
Risk Identification 5
FTA, and Fishbone FMEA, FTA, and or FTA, lacking analysis in FMEA or unclear or missing
diagrams. Fishbone diagrams. depth. FTA. analysis tools.
All risks prioritized Most risks prioritized Risks prioritized with Partial prioritization Incomplete
accurately with well- accurately with RPN values; some with limited prioritization; little to
Risk Assessment 5
justified RPN values, reasonable RPN values justification justification of RPN no justification for RPN
refined by SWIFT analysis. and SWIFT insights. provided. values. values.
Comprehensive, realistic Effective mitigation Basic mitigation plan Limited mitigation
Inadequate plan, with
plan addressing all high- plan covering most covering main risks plan: some risks are
Mitigation Plan unrealistic or no 4
priority risks with creative high-priority risks with with reasonable not adequately
solutions for key risks.
solutions. practical solutions. solutions. addressed.
Report is unclear or
Well-organized, concise Organized report with Report is clear but Report lacks clarity,
disorganized in
report with professional clear language and may lack detail or organization, or
Report Quality multiple sections; 1
language, visuals, and relevant visuals, minor organization in some citations in most
frequent citation
proper citations. citation issues. sections. sections.
issues.
Turnitin report Turnitin report
Turnitin report submitted No Turnitin report or
Turnitin Report submitted with <15% submitted with No Turnitin report
with <10% similarity and similarity >20%, 1
Compliance similarity and minimal <20% similarity and submitted.
no AI detection. significant AI detection.
AI detection. minor AI detection.
TOTAL MARKS 25