Standard Operating Procedure for Quality Risk Management for Equipment
1) Purpose
The purpose of this SOP is to establish procedures for conducting quality risk management (QRM) activities related to equipment used in the manufacturing of dental dosage forms, ensuring that risks associated with equipment operation, maintenance, and validation are identified, assessed, and mitigated.
2) Scope
This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry, where QRM principles are applied to manage equipment-related risks.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for overseeing QRM activities. Engineering and validation personnel are responsible for conducting risk assessments and implementing risk mitigation strategies. Production supervisors and operators are responsible for following risk control measures during equipment operation.
4) Procedure
4.1 Risk Identification
4.1.1 Identify potential risks associated with equipment operation, maintenance, and validation through systematic review and analysis.
4.1.2 Classify identified risks based on severity, probability of occurrence, and detectability.
4.2 Risk Assessment
4.2.1 Conduct qualitative or quantitative risk assessments to evaluate the impact of identified risks on product quality, patient safety, and regulatory compliance.
4.2.2 Prioritize risks based on assessment results to focus resources on managing high-risk areas.
4.3 Risk Mitigation
4.3.1 Develop risk mitigation strategies
4.3.2 Implement risk controls through documented procedures, including equipment design improvements, operational controls, and validation activities.
4.4 Risk Monitoring and Review
4.4.1 Monitor effectiveness of implemented risk controls through ongoing monitoring and periodic review.
4.4.2 Update risk assessments and mitigation strategies as needed based on new information, changes in equipment or processes, or emerging risks.
4.5 Documentation and Reporting
4.5.1 Document all QRM activities, including risk assessments, mitigation plans, and monitoring results.
4.5.2 Prepare periodic reports on QRM activities for review by QA and management.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QRM – Quality Risk Management
QA – Quality Assurance
6) Documents, if any
Risk Assessment Reports
Risk Mitigation Plans
QRM Procedures
QRM Review Reports
7) Reference, if any
ICH Q9: Quality Risk Management guidelines
Company-specific QRM policies and procedures
8) SOP Version
Version 1.0