115 lines
2.7 KiB
Markdown
115 lines
2.7 KiB
Markdown
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# Standard Operating Procedure: Management Review
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| Document ID | SOP-005 |
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| Title | Management Review |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Quality Assurance |
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---
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## 1. Purpose
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To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
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## 2. Scope
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This procedure applies to the periodic management review of the QMS, including all processes and quality objectives.
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## 3. Frequency
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Management reviews shall be conducted:
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- At least annually
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- More frequently if significant changes occur
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- As needed based on quality performance
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## 4. Responsibilities
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### 4.1 Quality Manager
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- Prepares management review agenda and materials
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- Facilitates the meeting
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- Documents meeting minutes and action items
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- Tracks completion of action items
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### 4.2 Top Management
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- Attends management review meetings
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- Reviews QMS performance data
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- Makes decisions on QMS improvements
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- Allocates resources as needed
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### 4.3 Department Managers
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- Provides input data for their areas
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- Attends management review
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- Implements assigned action items
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## 5. Management Review Inputs
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The following shall be considered:
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### 5.1 Actions from Previous Reviews
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- Status of action items
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- Effectiveness of implemented actions
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### 5.2 Changes in Context
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- Internal changes (organization, resources)
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- External changes (regulations, market)
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### 5.3 QMS Performance
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- Customer satisfaction and feedback
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- Quality objectives achievement
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- Process performance metrics
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- Nonconformities and corrective actions
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- Audit results
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- Supplier performance
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### 5.4 Resource Adequacy
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- Personnel
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- Infrastructure
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- Work environment
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### 5.5 Risk and Opportunities
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- Risk assessment results
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- Effectiveness of risk controls
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- New opportunities identified
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### 5.6 Improvement Opportunities
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- Process improvements
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- Product improvements
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- QMS enhancements
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## 6. Management Review Outputs
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Decisions and actions related to:
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- Improvement of QMS and processes
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- Product improvement
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- Resource needs
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- Changes to quality policy or objectives
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## 7. Documentation
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### 7.1 Meeting Minutes
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- Date and attendees
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- Items discussed
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- Decisions made
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- Action items with owners and due dates
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### 7.2 Record Retention
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- Management review records retained for 5 years
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- Available for regulatory inspection
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## 8. Related Documents
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- FRM-008 Management Review Agenda Template
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- FRM-009 Management Review Minutes Template
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---
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## Revision History
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| Rev | Date | Description | Author |
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|-----|------|-------------|--------|
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| 1.0 | [DATE] | Initial release | [AUTHOR] |
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