Quality System Procedure - Management Review

Most recently edited by: Paul VanderWeele
Most recent edit date: Feb 4, 2021
Edits were authorized by: Paul VanderWeele

Purpose

To regularly review the quality management system, risk exposure, and impartiality by the laboratory’s quality management team. To ensure that: the quality management system continues to be effective and suitable fulfilling the changing and future needs of the laboratory and its customers the quality management system is updated as necessary the results of Internal Audits are reviewed the defined quality management system is being implemented and followed * Review of threats to impartiality

Scope / Field of Application

Laboratory Quality Management System

Definitions and Acronyms

Management Review – formal evaluation by top management of the status and adequacy of the quality management system in relation to quality policy and objectives. Responsibility The Quality Management Team shall: call Management Reviews at regular intervals - not greater than twelve months, or more frequently at his/her discretion decide who should attend allocate follow-up actions and timelines to specific personnel provide a summary of the Internal Audit reports that have been completed since the last Management Review meeting archive the Minutes of the meeting as Quality Records provide a summary of the Corrective Action reports and Customer Complaints raised since the last Management Review meeting - paying particular attention to those which remain unresolved provide a summary of supplier/subcontractor performance reports since the last Management review meeting evaluate risk to impartiality based on review items including: Ownership Management Personnel Resources Finances Marketing/Branding Sales Practices Materials Required Internal audit reports Management review meeting minutes Corrective Action Requests Customer complaints

Procedure

The minutes taken reflect the following items:

  1. Date, attendees, and the individual completing the minutes.

  2. A review of the minutes from the previous management review and any action items.

  3. New items for review may include:

  4. Business planning – forecasting
  5. Internal audit status
  6. Corrective actions
  7. Preventive actions
  8. Process improvements
  9. Training (issues and needs)
  10. Equipment (calibration and maintenance program)
  11. Customer complaints
  12. Resources - personnel (absence, increasing work load, surprises from customers)
  13. Resources - equipment (time, capacity, failure)
  14. External audits
  15. Quality policy statement
  16. Customer satisfaction
  17. Quality goals

  18. Proficiency results

  19. Discussion may identify trends.

  20. Action items that are identified should be assigned to individuals and an appropriate completion date agreed upon. Any communication plan is noted.
  21. Any other business discussed is recorded with action items as appropriate. Documentation Minutes from the Management Review meeting are signed by the Quality Management Team and the Quality Manager. They are maintained by the Quality Management Team. Mitigated Risks- Any risk exposures identified during the review will trigger a Cause Analysis Assessment. The assessment will identify the root cause of the potential risk, a plan of actions for mitigating the risk, and the communications connected to these actions necessary to provide transparency and create awareness to the staff and management intended to minimize future potential threats to impartiality.