PHARMACEUTICAL CONTINUOUS IMPROVEMENT CHECKLIST

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--- DATA COLLECTION & ANALYSIS ---
[ ] Batch Yield (%)
[ ] Process Cycle Time (minutes)
[ ] Equipment Status (Operational/Downtime/Maintenance) (Operational, Downtime, Maintenance)
[ ] Date of Data Collection
[ ] Rejection Rate (%)
[ ] Observations / Notes

--- PROCESS MAPPING & IDENTIFICATION OF WASTE ---
[ ] Current Process Description
[ ] Types of Waste Identified (TIMWOODS) (Transportation, Inventory, Motion, Waiting, Overproduction, Over-processing, Defects, Skills (Underutilized))
[ ] Cycle Time (Current)
[ ] Lead Time (Current)
[ ] Bottleneck(s) Identified
[ ] Description of Waste & Impact
[ ] Mapping Technique Used (e.g., Value Stream Mapping) (Value Stream Mapping, Swimlane Diagram, Process Flowchart, SIPOC)
[ ] Process Map Image/Document

--- ROOT CAUSE ANALYSIS ---
[ ] Describe the Problem/Event
[ ] Initial Hypothesis for Root Cause(s) (Equipment Failure, Process Deviation, Human Error, Material Issue, Documentation Error, Other (Specify in Long Text))
[ ] Describe Investigation Methods Used (e.g., 5 Whys, Fishbone Diagram)
[ ] Number of 'Whys' Applied (if using 5 Whys)
[ ] Detailed Description of Root Cause(s) Determined
[ ] Contributing Factors (Select all that apply) (Lack of Training, Inadequate Supervision, Poor Communication, Insufficient Resources, Design Flaw, Other (Specify in Long Text))
[ ] Date of Root Cause Determination
[ ] Signature of Investigator

--- SOLUTION DEVELOPMENT & IMPLEMENTATION ---
[ ] Detailed Description of Proposed Solution
[ ] Estimated Cost of Implementation (USD)
[ ] Planned Start Date of Implementation
[ ] Estimated Completion Date of Implementation
[ ] Implementation Approach (e.g., Phased, Full Rollout) (Phased Rollout, Full Rollout, Pilot Program)
[ ] Resources Required (Select all that apply) (Personnel, Equipment, Software, Budget)
[ ] Approving Manager Signature

--- STANDARD OPERATING PROCEDURE (SOP) UPDATES ---
[ ] SOP Revision Category (Corrective Action, Preventative Action, Process Improvement, Regulatory Requirement)
[ ] Summary of Changes
[ ] Previous SOP Version (for comparison)
[ ] Revised SOP Document
[ ] SOP Review Date
[ ] Approval Status (Draft, Pending Review, Approved, Rejected)
[ ] Reviewer Signature

--- TRAINING AND COMMUNICATION ---
[ ] Training Program Description
[ ] Training Delivery Method (Instructor-Led, Online, Blended)
[ ] Training Completion Date
[ ] Number of Employees Trained
[ ] Topics Covered in Training (SOP Updates, New Equipment, Regulatory Changes, Process Improvements)
[ ] Training Materials (e.g., presentations, videos)
[ ] Employee Acknowledgement of Training

--- MONITORING AND MEASUREMENT ---
[ ] Cycle Time Reduction (%)
[ ] Defect Rate (per batch)
[ ] Equipment Uptime (%)
[ ] Overall Effectiveness Rating (Scale of 1-5) (1 - Poor, 2 - Fair, 3 - Average, 4 - Good, 5 - Excellent)
[ ] Date of Measurement
[ ] Time of Measurement
[ ] Comments/Observations

--- FEEDBACK AND ITERATION ---
[ ] Summary of User Feedback Received
[ ] Number of Users Providing Feedback
[ ] Overall Sentiment of Feedback (Positive, Negative, Neutral) (Positive, Negative, Neutral)
[ ] Specific Suggestions for Improvement
[ ] Areas of Process Needing Further Refinement (Select all that apply) (Efficiency, Clarity, User Experience, Compliance, Communication)
[ ] Date of Feedback Review

--- DOCUMENTATION AND REPORTING ---
[ ] Report Creation Date
[ ] Summary of Improvements Implemented
[ ] Number of Process Steps Modified
[ ] Estimated Cost Savings (USD)
[ ] Supporting Data/Graphs
[ ] Report Distribution Method (Email, Shared Drive, Printed Copy)
[ ] Approver Signature
[ ] Comments/Notes/Next Steps

--- RISK ASSESSMENT & MITIGATION ---
[ ] Describe Potential Risks Associated with the Improvement
[ ] Assign Risk Severity Score (1-10)
[ ] Assign Risk Probability Score (1-10)
[ ] Risk Category (e.g., Quality, Safety, Compliance) (Quality, Safety, Compliance, Financial, Reputational)
[ ] Proposed Mitigation Strategies
[ ] Residual Risk Severity Score (After Mitigation)
[ ] Date Mitigation Plan Implemented
[ ] Mitigation Plan Review & Approval

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