5.9 Assuring the Quality of Test Results

5.9.1 Quality Control Procedures
The laboratory has quality control procedures to validate the results of tests undertaken according to Volume II, Section 2, ORA-LAB.5.9 Assuring the Quality of Test Results.

The monitoring data is recorded in such a way that trends may be detected, for example, statistical process control charts. Monitoring activities are planned and evaluated according to Volume II, Section 2, ORA-LAB.5.9 Assuring the Quality of Test Results. Monitoring techniques may include, but are not limited to, the following:

1. Scheduled use of certified reference materials and internally generated reference materials;
2. Scheduled participation in interlaboratory comparison or proficiency-testing and calibration programs as described in ORA DFS.2, National Check Sample Program;
3. Replicate tests using the same or different methods;
4. Retesting of reference materials and retained customer samples; and
5. Correlation of results from tests conducted for different characteristics of a sample.

5.9.2
The laboratory has defined the criteria for quality control data and performs analysis by such means as control charting.  When data is found to be outside the established criteria, action is taken in accordance with the laboratory’s control of non-conforming work procedure. 

Related Procedures

• Volume II, Section 2, ORA-LAB.5.9 Assuring the Quality of Test Results
• ORA.DFS.2, National Check Samples Program
  See at http://intranet.ora.fda.gov/dfs/policies/sops/
• ORA-DFS.1, Microbiological Controls for Sample Analysis
  See at http://intranet.ora.fda.gov/dfs/policies/sops/ 
• ORA laboratory procedure for handling control of non-conforming work