ORA Laboratory Policies
Food and Drug Administration
Sources for needed improvements and potential sources of non-conformance are identified according to the process described in the laboratory’s preventive action procedure, and are part of the management review process. Preventive actions plans are developed, implemented, and monitored to address the identified opportunities for improvement.
The procedure includes the initiation of action. The management review process monitors the effectiveness of such actions in providing improvement to the management system.
- Each ORA laboratory has a preventive action procedure. A template is provided. See Volume II, Section 1, ORA-LAB.4.12 Preventative Action.
- Each ORA laboratory has a management review procedure. A template is provided. See Volume II, Section 1, ORA-LAB.4.15, Management Review.
- ORA-QMS.008, Preventive Action Procedure.
- ORA-QMS.003, Management Review