Audits and Review
Management Review Report
Evaluate quality system effectiveness through executive assessment and strategic planning for continuous improvement.
Summary
A Management Review Report documents the periodic evaluation of your Quality Management System (QMS) by top management. It provides a systematic assessment of QMS performance through Key Performance Indicators (KPIs), audit results, customer feedback, and process effectiveness. The report demonstrates management commitment to quality and drives strategic decisions for continuous improvement of your medical device quality system.Why is a Management Review Report important?
The Management Review Report exists because regulatory frameworks require top management to take active responsibility for quality management system effectiveness. It’s not sufficient for management to simply approve procedures - they must regularly evaluate whether the entire quality system is working and achieving its intended outcomes. For medical device manufacturers, the Management Review Report is crucial because it demonstrates executive oversight to regulatory authorities and notified bodies. It shows that quality decisions are made at the highest organizational level with full awareness of system performance. The report drives strategic quality planning by identifying trends, resource needs, and improvement opportunities that require management attention. Without systematic management review, you risk quality system drift, missed improvement opportunities, and regulatory findings related to inadequate management responsibility for quality.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Management responsibility is mandatory under Section 820.20
- Management reviews are required under Section 820.20(c) with executive oversight
- Must review QMS effectiveness and adequacy of resources
- Results must drive quality planning and improvement activities
Special attention required for:
- Management responsibility (820.20) - executives must actively participate in quality decisions
- Quality planning (820.20(b)) - management reviews inform strategic quality planning
- CAPA system oversight (820.100) - management must review CAPA effectiveness
- Resource management (820.25) - reviews must address adequacy of quality resources
Guide
Your Management Review Report must systematically evaluate QMS performance and drive strategic quality decisions. The report transforms operational data into management insights that guide resource allocation and improvement priorities.1. Overall QMS Assessment
The management review assessment provides your executive summary of quality system performance. This section requires you to synthesize information from multiple sources - audit results, KPI performance, customer feedback, and process metrics - into a clear management perspective on QMS effectiveness. You must address whether your quality system is suitable (appropriate for your organization and products), adequate (sufficient to meet regulatory requirements), and effective (achieving intended quality outcomes). If performance meets expectations, state this clearly with supporting evidence. If improvements are needed, identify specific areas requiring management attention and resource allocation.2. Key Performance Indicator Review
The KPI assessment table provides the detailed data that supports your overall QMS assessment. For each quality process, you must evaluate actual performance against established acceptance criteria and provide a management assessment of results. Your KPI review should cover all critical quality processes including document control, human resources, software development, risk management, change management, customer feedback, vigilance, CAPA, deployment, validation, post-market surveillance, internal audits, clinical evaluation, regulatory updates, purchasing, sales, and usability engineering. For each KPI, document the actual data collected during the review period, compare it to acceptance criteria, provide a management assessment of performance, identify any improvement measures needed, and evaluate the effectiveness of previous improvement measures. This systematic approach ensures comprehensive coverage of quality system performance.3. Management Signatures and Accountability
The management review signatures section establishes clear accountability for quality decisions. You must identify the management team members who participated in the review and obtain their formal commitment to the findings and resulting actions. Include the position, name, and signature of each management team member involved in the review. This typically includes senior executives, quality management, and other key decision-makers who have authority to allocate resources and drive organizational change. The signatures demonstrate that management has reviewed the data, understands the implications, and commits to supporting necessary improvements.4. Review Timing and Follow-up
Document the date of review and establish clear timelines for implementing any improvement measures identified during the review. The management review should occur at planned intervals (typically annually) but may be conducted more frequently if significant quality issues arise. Ensure that review findings are properly communicated throughout the organization and that responsible personnel understand their roles in implementing improvement measures. Plan for follow-up activities to verify that improvement measures are effective and achieving intended outcomes.Example
Scenario: You conduct your annual management review covering the previous 12 months of QMS performance. The review shows that most KPIs are meeting acceptance criteria, but training completion rates have dropped slightly and there’s been an increase in customer feedback requiring response. Management decides to implement automated training reminders and enhance the customer feedback process to improve performance in these areas.Complete Management Review Report Document
Management Review Report ID: MRR-2024-0011. Scope
This report provides the results of the management review of the quality management system (QMS) performed according to SOP Management Review. The review was conducted to assess the suitability, adequacy, and effectiveness of the QMS and to identify opportunities for improvement, if needed.2. Management Review Assessment
Overall QMS Assessment: The quality management system has performed effectively during the 2023 review period, with 22 of 24 key performance indicators meeting or exceeding acceptance criteria. The QMS demonstrates strong suitability for our medical device operations and adequate resource allocation to maintain regulatory compliance. Two areas require management attention: training completion rates have decreased from 98% to 92%, and customer feedback response time has increased slightly. These issues do not indicate systemic failures but represent opportunities for process enhancement through improved automation and resource allocation. The QMS continues to be effective in maintaining product quality, regulatory compliance, and customer satisfaction. No major changes to the quality system structure are required, but targeted improvements in training management and customer communication will enhance overall performance.2.1 Management Signatures
Date of Review: March 20, 2024| Position | Name | Signature |
|---|---|---|
| Chief Executive Officer | Robert Chen | R. Chen |
| Chief Technology Officer | Sarah Martinez | S. Martinez |
| Quality Manager | David Kim | D. Kim |
| Regulatory Affairs Manager | Jennifer Lopez | J. Lopez |
3. QMS and Key Performance Indicator Review
| Process | Key Performance Indicator | Data on KPI | Management Assessment | Improvement Measures | Evaluation of Previous Measures |
|---|---|---|---|---|---|
| Quality Manual | All quality objectives are met | 100% of objectives met | QMS is effective and meets requirements | None | N/A |
| Document and Record Control | Archived documents maintained for device lifetime | 100% of documents retained | Document management process is effective | None | N/A |
| Document and Record Control | No process non-conformities during external audits | 0 non-conformities | Document management process is effective | None | N/A |
| Human Resources | Initial training completion rate for employees | 92% of employees complete | Training process needs improvement | Implement automated training reminders | Previous manual tracking was insufficient |
| Integrated Software Development | Software system testing with limited failures | Failure under 25% of testing | Software development process is effective | None | N/A |
| Integrated Software Development | Known software anomalies lead to no adverse events | 0 adverse events due to known software anomalies | Software development process is effective | None | N/A |
| Software Problem Resolution | Efficient investigation and resolution of software problems | 94% of problems resolved successfully | Software problem resolution process is effective | None | N/A |
| Risk Management | Number of unacceptable risks mitigated | 100% of unacceptable risks mitigated with risk controls | Risk management process is effective | None | N/A |
| Risk Management | Risk controls successfully implemented | 100% of risk controls implemented | Risk management process is effective | None | N/A |
| Change Management | No non-conformities due to incomplete change documentation | 0 non-conformities | Change management process is effective | None | N/A |
| Feedback and Customer Management | Customer feedback response rate | 78% of feedback processed | Customer feedback process needs improvement | Enhance response tracking system | Previous informal tracking was inadequate |
| Vigilance | Incidents reported within legal reporting deadlines | 100% of incidents reported | Vigilance process is effective | None | N/A |
| Corrective and Preventative Action | CAPA closure rate | 93% of CAPAs closed | CAPA process is effective | None | N/A |
| Deployment | No deployment without prior system testing | 100% of deployments tested | Deployment process is effective | None | N/A |
| Software Validation | Software validation completed for all necessary software | 100% of software validated | Software validation process is effective | None | N/A |
| Post-Market Surveillance | PMS Report, PSUR, or Summary of Safety and Clinical Performance delivered within timeframe required | 0 late reports | Post-market surveillance process is effective | None | N/A |
| Internal Audit | Number of internal audits completed on schedule | 100% of audits completed | Internal audit process is effective | None | N/A |
| Clinical Evaluation | On-time and as planned PMCF activities | PMCF activities conducted on schedule | Clinical evaluation process is effective | None | N/A |
| Management Review | Frequency of management review meetings | 1 meeting annually completed | Management review process is effective | None | N/A |
| Update of Regulations | Regulatory updates identified and implemented within six months of publication effective dates | Updates implemented within 4 months average | Regulatory update process is effective | None | N/A |
| Product Registration and Certification | Zero unsuccessful attempts of Notified Body assessment due to incomplete documentation | No failed assessments due to documentation issues | Registration process is effective | None | N/A |
| Purchasing | Supplier acceptance on surveillance | 8% of suppliers moved from accepted to blocked during surveillance | Purchasing process is effective | None | N/A |
| Sales | Sales and marketing materials approved prior to use | 100% of materials approved prior to use | Sales process is effective | None | N/A |
| Usability and Human Factors Engineering | Usability testing with no failed critical tasks | 100% of usability critical tasks passed | Usability engineering process is effective | None | N/A |
Annex 1 - KPI Acceptance Criteria
The following acceptance criteria were used to evaluate the KPIs:| Process | KPI | Acceptance Criteria | Primary Responsibility |
|---|---|---|---|
| Quality Manual | All quality objectives are met | 100% of objectives met | Quality |
| Document and Record Control | Archived documents maintained for device lifetime | 100% of documents retained | Quality |
| Document and Record Control | No process non-conformities during external audits | 0 non-conformities | Quality |
| Human Resources | Initial training completion rate for employees | 95% of employees complete | Corporate |
| Integrated Software Development | Software system testing with limited failures | Failure under 30% of testing | Software |
| Integrated Software Development | Known software anomalies lead to no adverse events | 0 adverse events due to known software anomalies | Software |
| Software Problem Resolution | Efficient investigation and resolution of software problems | Greater than 90% of problems resolved successfully | Software |
| Risk Management | Number of unacceptable risks mitigated | 100% of unacceptable risks mitigated with risk controls | Quality |
| Risk Management | Risk controls successfully implemented | 100% of risk controls implemented | Quality |
| Change Management | No non-conformities due to incomplete change documentation | 0 non-conformities | Quality |
| Feedback and Customer Management | Customer feedback response rate | Over 80% of feedback processed | Quality |
| Vigilance | Incidents reported within legal reporting deadlines | 100% of incidents reported | Quality |
| Corrective and Preventative Action | CAPA closure rate | Over 90% of CAPAs closed | Quality |
| Deployment | No deployment without prior system testing | 100% of deployments tested | Software |
| Software Validation | Software validation completed for all necessary software | 100% of software validated | Software |
| Post-Market Surveillance | PMS Report, PSUR, or Summary of Safety and Clinical Performance delivered within timeframe required | 0 late reports | Quality |
| Internal Audit | Number of internal audits completed on schedule | 100% of audits completed | Quality |
| Clinical Evaluation | On-time and as planned PMCF activities | PMCF activities conducted on schedule | Quality |
| Management Review | Frequency of management review meetings | At least 1 meeting annually | Management |
| Update of Regulations | Regulatory updates identified and implemented within six months of publication effective dates | Updates implemented within 6 months | Quality |
| Product Registration and Certification | Zero unsuccessful attempts of Notified Body assessment due to incomplete documentation | No failed assessments due to documentation issues | Quality |
| Purchasing | Supplier acceptance on surveillance | Under 10% of suppliers moved from accepted to blocked during surveillance | Product |
| Sales | Sales and marketing materials approved prior to use | 100% of materials approved prior to use | Business |
| Usability and Human Factors Engineering | Usability testing with no failed critical tasks | 100% of usability critical tasks passed | Quality |
Q&A
How often should management reviews be conducted?
How often should management reviews be conducted?
Management reviews must be conducted at least annually, but may be performed more frequently if significant quality issues arise or if required by your quality management system procedures.
Who must participate in management reviews?
Who must participate in management reviews?
Management reviews require participation by personnel with executive responsibility for the QMS. This typically includes senior management, quality management, and other key decision-makers who can authorize resource allocation and organizational changes.
What data should be included in the management review?
What data should be included in the management review?
Management reviews should include audit results, customer feedback, process performance data, nonconformities, corrective actions, regulatory changes, and resource adequacy. The specific data depends on your QMS scope and organizational structure.
How do management review findings connect to quality planning?
How do management review findings connect to quality planning?
Management review findings must drive quality planning activities, including resource allocation, process improvements, training needs, and strategic quality objectives for the coming period.
What should be done if KPIs are not meeting acceptance criteria?
What should be done if KPIs are not meeting acceptance criteria?
When KPIs fail to meet acceptance criteria, management must identify root causes, implement improvement measures, and establish timelines for corrective action. The effectiveness of these measures should be evaluated in subsequent reviews.
How should management review records be maintained?
How should management review records be maintained?
Management review records must be maintained as controlled documents with appropriate retention periods. They serve as evidence of management commitment and must be available for regulatory inspections and notified body assessments.