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Creating Standard Operating Procedures for your Manager Of Quality Assurance work can be difficult and take time. That’s why we’ve created these example Manager Of Quality Assurance SOPs so you can jumpstart your SOP creation process. We want to help you set up your Quality Assurance systems and processes by taking these sample SOPs and building out your own SOPs template library. By having all your Quality Assurance procedures in one place, your team will have the information they need at all times. Let’s look at some Manager Of Quality Assurance SOP examples.
1. Document Control: The purpose of this SOP is to establish a systematic approach for managing and controlling all quality-related documents within the organization. It includes procedures for document creation, review, approval, distribution, and revision. The scope of this SOP covers all quality-related documents, including policies, procedures, work instructions, forms, and records. The Manager of Quality Assurance is responsible for ensuring compliance with this SOP. References to other SOPs include the Change Control SOP for managing document revisions and the Training and Competency SOP for ensuring employees are trained on document control procedures.
2. Internal Audits: This SOP outlines the process for conducting internal audits to assess the effectiveness of the quality management system. The purpose of internal audits is to identify areas of non-compliance, potential risks, and opportunities for improvement. The scope of this SOP includes planning, conducting, reporting, and follow-up of internal audits. The Manager of Quality Assurance is responsible for coordinating and overseeing internal audits. References to other SOPs include the Corrective and Preventive Action (CAPA) SOP for addressing non-compliance findings and the Management Review SOP for reporting audit results to top management.
3. Supplier Qualification: The purpose of this SOP is to establish criteria and procedures for evaluating and qualifying suppliers to ensure they meet the organization’s quality requirements. The scope of this SOP covers the entire supplier qualification process, including supplier evaluation, selection, and ongoing monitoring. The Manager of Quality Assurance is responsible for managing supplier qualification activities. References to other SOPs include the Purchasing and Receiving SOP for integrating supplier qualification into the procurement process and the Non-Conforming Material Control SOP for addressing non-compliant supplier products.
4. Training and Competency: This SOP outlines the process for identifying training needs, developing training programs, and ensuring employees are competent to perform their assigned tasks. The purpose of this SOP is to ensure that employees have the necessary knowledge and skills to meet quality requirements. The scope of this SOP covers all employees within the organization. The Manager of Quality Assurance is responsible for coordinating and overseeing training and competency activities. References to other SOPs include the Job Descriptions SOP for defining job-specific training requirements and the Performance Evaluation SOP for assessing employee competency.
5. Corrective and Preventive Action (CAPA): The purpose of this SOP is to establish a systematic approach for identifying, investigating, and addressing non-compliance issues and potential risks. The scope of this SOP covers the entire CAPA process, including problem identification, root cause analysis, corrective action implementation, and effectiveness verification. The Manager of Quality Assurance is responsible for managing the CAPA process. References to other SOPs include the Non-Conforming Material Control SOP for addressing non-compliant products and the Change Control SOP for implementing corrective actions that require process or document changes.
6. Risk Management: This SOP outlines the process for identifying, assessing, and managing risks that could impact the quality of products or services. The purpose of this SOP is to proactively mitigate risks and ensure continuous improvement. The scope of this SOP covers risk identification, risk assessment, risk mitigation, and risk monitoring. The Manager of Quality Assurance is responsible for overseeing risk management activities. References to other SOPs include the Change Control SOP for assessing risks associated with process or document changes and the Management Review SOP for reporting risk management activities to top management.
7. Calibration and Maintenance: The purpose of this SOP is to establish procedures for calibrating and maintaining equipment and instruments used in quality assurance activities. The scope of this SOP covers all equipment and instruments that directly or indirectly impact product quality. The Manager of Quality Assurance is responsible for ensuring compliance with calibration and maintenance procedures. References to other SOPs include the Non-Conforming Material Control SOP for addressing non-compliant equipment and the Document Control SOP for managing calibration and maintenance records.
8. Statistical Process Control (SPC): This SOP outlines the process for implementing and maintaining statistical process control techniques to monitor and control process variability. The purpose of SPC is to ensure that processes are stable and capable of meeting quality requirements. The scope of this SOP covers the selection of control charts, data collection, analysis, and interpretation. The Manager of Quality Assurance is responsible for overseeing the implementation and maintenance of SPC. References to other SOPs include the Corrective and Preventive Action (CAPA) SOP for addressing out-of-control processes and the Training and Competency SOP for training employees on SPC techniques.
9. Change Control: The purpose of this SOP is to establish procedures for managing changes that could impact the quality management system, processes, or products. The scope of this SOP covers the identification, evaluation, approval, implementation, and verification of changes. The Manager of Quality Assurance is responsible for managing the change control process. References to other SOPs include the Document Control SOP for managing document changes and the Risk Management SOP for assessing risks associated with changes.
10. Management Review: This SOP outlines the process for conducting periodic management reviews to evaluate the effectiveness of the quality management system and identify opportunities for improvement. The purpose of management reviews is to ensure that quality objectives are met and that the quality management system remains suitable, adequate, and effective. The scope of this SOP covers the planning, preparation, conduct, and follow-up of management reviews. The Manager of Quality Assurance is responsible for coordinating and facilitating management reviews. References to other SOPs include the Internal Audits SOP for reporting audit findings and the Corrective and Preventive Action (CAPA) SOP for addressing improvement opportunities identified during management reviews
Looking for SOP templates for your Manager Of Quality Assurance work? We’ve got you covered. You can build out your company SOPs using the sample SOP information above (added to our template) or our team can put together a starter SOPs template based on your Manager Of Quality Assurance work. Get in touch if you’ve got questions about the quickest way to build out your Quality Assurance SOPs library.
