Evaluate quality system effectiveness through executive assessment and strategic planning for continuous improvement.
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 |
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 |
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 |
How often should management reviews be conducted?
Who must participate in management reviews?
What data should be included in the management review?
How do management review findings connect to quality planning?
What should be done if KPIs are not meeting acceptance criteria?
How should management review records be maintained?