PHARMACEUTICAL QUALITY RISK MANAGEMENT CHECKLIST

Created by ChecklistGuro (https://checklistguro.com)


--- RISK IDENTIFICATION ---
[ ] Brief Description of Process/Activity
[ ] Potential Hazard/Risk Description
[ ] Process Steps Involved (Select All That Apply) (Raw Material Sourcing, Manufacturing, Packaging, Storage, Distribution, Cleaning/Sanitation)
[ ] Regulatory/Guidance Relevance (GMP Regulations, ICH Guidelines, Company SOPs, Other (Specify))
[ ] Date of Initial Risk Identification
[ ] Identification Source (e.g., Audit Findings, Deviation Reports)

--- RISK ANALYSIS - SEVERITY ASSESSMENT ---
[ ] Potential Impact on Patient Safety (Negligible, Minor, Moderate, Major, Critical)
[ ] Potential Impact on Product Quality (None, Minor Deviation, Significant Deviation, Batch Rejection, Product Recall)
[ ] Estimated Number of Patients Potentially Affected
[ ] Description of Potential Adverse Effects
[ ] Impact on Regulatory Compliance (No Impact, Minor Deviation, Significant Deviation, Potential Warning Letter)
[ ] Estimated Financial Loss (if applicable)

--- RISK ANALYSIS - PROBABILITY ASSESSMENT ---
[ ] Probability Scale Value (1-5)
[ ] Justification for Probability Rating
[ ] Frequency of Occurrence (Once per year or less, Several years, Several months, Several weeks, Several days, Daily)
[ ] Factors Influencing Probability
[ ] Estimated Frequency (Events/Year)

--- RISK EVALUATION - PRIORITIZATION ---
[ ] Severity Score
[ ] Probability Score
[ ] Risk Score (Severity x Probability)
[ ] Risk Priority Category (High, Medium, Low)
[ ] Justification for Prioritization
[ ] Risk Ownership Assigned (Quality Assurance, Manufacturing, Engineering, Other)

--- RISK CONTROL MEASURES - EXISTING ---
[ ] Detailed Description of Existing Control
[ ] Control Type (e.g., Preventative, Detective, Corrective) (Preventative, Detective, Corrective)
[ ] Frequency of Control Execution (e.g., daily, weekly, monthly)
[ ] Last Review/Verification Date of Control
[ ] Applicable Regulations/Guidelines Controlled By (cGMP, ICH Guidelines, FDA Regulations, Company SOPs)
[ ] Reviewer Signature

--- RISK CONTROL MEASURES - PROPOSED ---
[ ] Detailed Description of Proposed Control
[ ] Estimated Cost of Implementation
[ ] Target Implementation Date
[ ] Responsible Department/Team (Manufacturing, Quality Assurance, Engineering, Supply Chain)
[ ] Control Type(s) (e.g., Administrative, Engineering, Procedural) (Administrative, Engineering, Procedural, Equipment Modification)
[ ] Supporting Documentation (e.g., SOP, Drawings)
[ ] Justification for Proposed Control

--- RISK CONTROL IMPLEMENTATION ---
[ ] Implementation Start Date
[ ] Planned Completion Date
[ ] Estimated Cost of Implementation
[ ] Description of Implementation Activities Performed
[ ] Implementation Status (Not Started, In Progress, Completed, Delayed)
[ ] Implemented By
[ ] Supporting Documentation (e.g., training records, SOP revisions)
[ ] Actual Cost of Implementation

--- RISK REVIEW & MONITORING ---
[ ] Last Review Date
[ ] Frequency of Review (in months)
[ ] Review Outcome (Satisfactory/Needs Improvement/Unsatisfactory) (Satisfactory, Needs Improvement, Unsatisfactory)
[ ] Summary of Review Findings
[ ] Corrective Actions Identified (if any)
[ ] Target Completion Date for Corrective Actions
[ ] Reviewer Signature
[ ] Risk Status after Review (Increased/Decreased/No Change) (Increased, Decreased, No Change)

--- DOCUMENTATION & RECORD KEEPING ---
[ ] Risk Assessment Review Date
[ ] Summary of Risk Assessment Findings
[ ] Supporting Documentation (e.g., protocols, reports)
[ ] Record Status (Active, Archived, Superseded) (Active, Archived, Superseded)
[ ] Document Version Number
[ ] Reviewer Signature
[ ] Comments/Notes Regarding Documentation

--- END OF TEMPLATE ---
Transform this text into a digital, automated, and trackable mobile app!
Visit: https://checklistguro.com/templates/pharmaceutical/pharmaceutical-quality-risk-management-checklist
(Click "Install Template" to launch your digital inspection tool immediately)