ORA Laboratory Policies
Food and Drug Administration
The sections following below address the factors affecting the correctness and reliability of the tests performed by a laboratory. These factors include contributions from:
- personnel (Volume II, Section 2, ORA-LAB.5.2 Personnel: Training Procedure),
- accommodation and environmental conditions (Volume II, Section 2, ORA-LAB.5.3 Facilities and Environmental Conditions),
- test and calibration methods and method selection and validation (Volume II, Section 2, ORA-LAB.5.4 Test Methods and Validation),
- equipment selection and calibration (Volume II, Section I, ORA-LAB.4.6 Purchasing and Receipt; Section 2, ORA-LAB.5.5 Equipment),
- measurement uncertainty and traceability (Volume II, Section 2, ORA-LAB.5.4 Test Methods and Validation; ORA-LAB.5.6 Measurement Traceability), and
- handling of test and calibration items (Volume II, Section 2, ORA-LAB.5.8 Sample Management).
The procedures listed in each section address these factors.
5.1.2 Contribution to Total Uncertainty of Measurement
These factors are considered in determining total measurement uncertainty and in developing uncertainty budgets. Additionally, these factors are considered by the laboratory when developing test procedures, in the training and qualification of personnel, and in the selection of the equipment utilized.