ORA Laboratory Policies
Food and Drug Administration
Each ORA laboratory has a corrective action procedure that designates the authorities for implementing corrective action when one of the following is identified:
- non-conforming work,
- departures from the policies and procedures in the management system, and
- departures from required technical operations.
4.11.2 Cause Analysis
The procedure for corrective action includes investigating and determining the root cause of the non-conformance.
4.11.3 Selection and Implementation of Corrective Actions
Potential corrective actions are identified. The action most likely to eliminate the problem and to prevent recurrence is selected.
The corrective action chosen addresses the magnitude of the non-conformance and the risk attributed to the non-conformance.
Corrective actions are documented, and any changes resulted from the corrective action investigation are implemented.
4.11.4 Monitoring of Corrective Actions
The corrective action procedure addresses the monitoring for the effectiveness of corrective actions performed.
4.11.5 Additional Audits
Where the identification of non-conformances or departures casts doubts on the laboratory’s conformance with management system policies and procedures or conformance with ISO/IEC 17025, the areas of activity affected by the non-conformance are audited as soon as possible in accordance with Volume I, Section 4.14 Internal Audits.
- Each ORA laboratory has its own corrective action procedure. A template is provided. See Volume II, Section 1, ORA-LAB.4.11 Corrective Action.
- ORA-QMS.007, Corrective Action Procedure.