• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Science & Research

  • Print
  • Share
  • E-mail

Volume I - 4.11 Corrective Action

DFS Pyramid Logo

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

4.11.1 General

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.

Related Procedures