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Management review training for bsc

Ashley James
Ashley James

This document summarizes Stryker's management review process. It discusses that senior and executive management must regularly review the quality system to ensure its adequacy, effectiveness, opportunities for improvement, need for changes, continuing suitability, and compliance evidence. Key metrics monitored include audit results, customer feedback, process and product performance, corrective actions, and changes that could affect the system. Management reviews evaluate goals, system control, issues needing escalation, and decisions on improvement. The document lists Stryker procedures and responsibilities for divisional and operations management reviews.

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Management review training for bsc
Understand what Management Review is and why it is important to the Quality System. What practices and procedures are in place at Stryker. Understand what metrics are monitored and reported during the Management Review.
Per 21 CFR Part 820, Subpart B and ISO 13485:2003 Senior and Executive level management will review an organizations quality system to ensure: Adequacy and Effectiveness Opportunities for Improvement Need for Changes. Continuing Suitability Evidence of Compliance
Results of internal and external audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions of previous management reviews. Changes that could affect the quality system. Recommendations for improvement.
Any decisions and actions related to: Improvement of the effectiveness of the quality management system and its processes Improvement of product related to customer requirements Resource needs.
Divisional Level Management Review Procedure 90644228 Operations Level Management Review Procedure 00-01-00
Management review training for bsc
Is the right data being reported to capture trends? Are goals being met, and are the goals set appropriate? Is the system in a state of control? Are there any issues and do they need to be escalated?
Department Person Responsible Complaints Allison Harris NCRs Ashley James CAPAs Ashley James PIRs/ Field Actions Josh Debruyn or Tara Lopez Training Cambria Rollo Internal Audits Ashley James External Audits Josh Debruyn Product Distribution Gerry Yarber Production and Process NCRs Ashley James Scrap Totals Denise Vargo Calibration Robert Keel Preventative Maintenance Brian Bowen Supplier Quality Roberto Reyes Inspection Cycle Time Saurabh Saini Environmental Monitoring Lucy Kong
Motivation..after manufacturing transfer 糸温岳艶..

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Management review training for bsc

  • 2. Understand what Management Review is and why it is important to the Quality System. What practices and procedures are in place at Stryker. Understand what metrics are monitored and reported during the Management Review.
  • 3. Per 21 CFR Part 820, Subpart B and ISO 13485:2003 Senior and Executive level management will review an organizations quality system to ensure: Adequacy and Effectiveness Opportunities for Improvement Need for Changes. Continuing Suitability Evidence of Compliance
  • 4. Results of internal and external audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions of previous management reviews. Changes that could affect the quality system. Recommendations for improvement.
  • 5. Any decisions and actions related to: Improvement of the effectiveness of the quality management system and its processes Improvement of product related to customer requirements Resource needs.
  • 6. Divisional Level Management Review Procedure 90644228 Operations Level Management Review Procedure 00-01-00
  • 8. Is the right data being reported to capture trends? Are goals being met, and are the goals set appropriate? Is the system in a state of control? Are there any issues and do they need to be escalated?
  • 9. Department Person Responsible Complaints Allison Harris NCRs Ashley James CAPAs Ashley James PIRs/ Field Actions Josh Debruyn or Tara Lopez Training Cambria Rollo Internal Audits Ashley James External Audits Josh Debruyn Product Distribution Gerry Yarber Production and Process NCRs Ashley James Scrap Totals Denise Vargo Calibration Robert Keel Preventative Maintenance Brian Bowen Supplier Quality Roberto Reyes Inspection Cycle Time Saurabh Saini Environmental Monitoring Lucy Kong