ORA Laboratory Policies
Food and Drug Administration
The laboratory’s management review procedure includes the schedule for conducting management reviews. This review is conducted by the laboratory’s executive management to ensure continuing fitness for use and effectiveness of the management system and to introduce needed changes or improvements.
The management review addresses the elements of the management system and includes but is not limited to the following elements:
- suitability of policies and procedures ( Volume II, Section 1, ORA-LAB.4.2 Management System);
- reports from managerial and supervisory personnel ( Volume II, Section 1, ORA-LAB.4.1 Organization);
- outcome of recent internal audits ( Volume II, Section 1, ORA-LAB.4.14 Audits);
- corrective and preventive actions ( Volume II, Section 1, ORA-LAB.4.11 Corrective Action Procedure, 4.12 Preventative Action Procedure);
- assessments by external bodies ( Volume II, Section 1, ORA-LAB.4.14 Audits);
- results of interlaboratory comparisons, proficiency test, and quality control (< Volume II, Section 2, ORA-LAB.5.9 Assuring the Quality of Test Results);
- changes in the volume and type of work ( Volume II, Section 1, ORA-LAB.4.4 Requests, Tenders and Contracts);
- customer feedback ( Volume II, Section 1, ORA-LAB.4.8 Complaints);
- complaints ( Volume II, Section 1, ORA-LAB.4.8 Complaints); and
- other factors, such as quality control activities, resources ( Volume II, Section 1, ORA-LAB.4.1 Organization) and staff training ( Volume II, Section 2, ORA-LAB.5.2 Personnel: Training Procedure).
The findings and the actions that arise from the review are recorded according to the laboratory's management review procedure. Each action includes a target date for resolution.
- Each ORA laboratory has its own management review procedure. A template is provided. See Volume II, Section 1, ORA-LAB.4.15 Management Review.
- ORA-QMS.003, Management Review.