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U.S. Department of Health and Human Services

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Volume I - 4.12 Preventive Action

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ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

VERSION NO.:2.0

ORA Laboratory Manual of Quality Policies

EFFECTIVE DATE:
10-01-03
REVISED:
05-02-14

4.12.1 General

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.

4.12.2 Procedure

The procedure includes the initiation of action. The management review process monitors the effectiveness of such actions in providing improvement to the management system.

Related Procedures