Deviation Handling and Quality Risk Management

What is Deviation Handling and Quality Risk Management:

Deviation Handling and Quality Risk Management

The Guidance Document Deviation Handling and Quality Risk Management in a series developed by WHO / EMP / HIS Quality, Safety and Standards Team on request from the manufacturers of the USAID's Funding Developing Countries Vaccination Manufacturer's Network (DCVMN).
A set of priorities has been identified by the manufacturer of vaccine for WHO to provide guidelines on expectations from the vaccine preclalation program.
Guidance document vaccines are aimed at newly manufactured manufacturers or require detailed guidance for the risk assessment for deviation management operations. This could be a useful guide to the National Regulatory Authorities (NRAs) in vaccine production countries.

These are not official WHO papers, but there are notes for guidance on assessment criteria in accordance with the preliminary diagnosis of vaccinations. These documents provide more explanations with examples that can be implemented based on WHO recommendations.

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Deviation Handling
Event Detection
Deviation Categorization
Deviation Treatment
Root Cause Investigation
Corrective and Preventive Actions (CAPA)
Quality Risk Management and Deviations
Quality Risk Management Steps
Risk Assessment
Risk Control
Risk Review
Risk Communication
Purpose of Quality Risk Management
Information Sources for QRM
QRM Tools
Examples of QRM for Production Processes
Training
Conclusions