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U.S. Department of Health and Human Services

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Volume I - 4.9 Control of Non-conforming Work

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ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

VERSION NO.:1.9

ORA Laboratory Manual of Quality Policies

EFFECTIVE DATE:
10-01-03
REVISED:
01-22-13

4.9.1 Procedure

The ORA laboratories have a control of non-conforming work procedure that is implemented when any aspect of their testing work, or the results of this work, does not conform to requirements of the management system, testing methods, or the requests of the customer. This procedure addresses the following elements:

  • responsibilities and authorities for the management of identified non-conforming work and taking actions such as the halting of work, the withholding of test reports; 
  • application of criteria to evaluate the significance of non-conforming work;
  • remedial action taken, together with any decision about the acceptability of the non-conforming work; 
  • notification of the customer, and if necessary, recall of work; and 
  • responsibility for authorizing the resumption of work.

4.9.2 Follow-Up

If the non-conforming work could recur, or there are other significant problems identified, the corrective action procedures in Volume I, Section 4.11 Corrective Action are promptly followed.

Related Procedures