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| ORA Laboratory Policies Food and Drug Administration |
| DOCUMENT NO.: ORA-LAB.QM | VERSION NO.:1.6 | ORA Laboratory Manual of Quality Policies | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/06/2008 |
4.15 Management Reviews
4.15.1 General
The laboratory's management review procedureincludes 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.
Related Procedures
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