ORA Laboratory Policies
Food and Drug Administration
Test reporting is addressed in the procedure found in Volume II, Section 2, ORA-LAB.5.10 Reporting Laboratory Data. This procedure gives the details for reporting data using consistent reporting formats for laboratory worksheets. Reports are reviewed against acceptance criteria that address accuracy, clarity and objectivity. Results are reported on analytical worksheets and in FACTS and/or LIMS.
5.10.2 Reporting Results
Data entered onto the worksheets and in FACTS includes all the information specified by ORA as described in the procedure ORA-LAB.5.10 Reporting Laboratory Data of Volume II and the FACTS manual. Other government agency-specified data is recorded by the laboratory on sample forms that accompany the samples.
5.10.3 Additional Requirements for Worksheets
126.96.36.199 Specific Requirements
The following information is included in test reports for the interpretation of the test results:
- Deviations from, additions to, or exclusions from the test method, and information on test conditions, such as environmental conditions;
- A statement of conformance or non-conformance with specifications;
- A statement of the estimated uncertainty of measurement when requested by a customer;
- Opinions and interpretations as detailed in Volume I, Section 5.10.5; and,
- Additional information that may be requested by methods, customers or groups of customers.
188.8.131.52 Sampling Results
In addition to the instructions listed in Sections 5.10.2 Reporting Results and 184.108.40.206 Specific Requirements, sampling information and conditions are posted to the laboratory for review on the FACTS sample collection record.
5.10.4 Calibration Certificates
ORA laboratories conduct in-house calibration activities on measuring and test equipment only and, therefore, do not issue calibration certificates. In-house calibrations are documented by a report, or sticker, or other suitable method,
5.10.5 Opinions and Interpretations
Laboratory management expresses its opinion and interpretation of the compliance or non-compliance of the results through the laboratory classification assigned to each sample. This laboratory classification is recorded in FACTS and/or LIMS and may be recorded on the FDA form FD-465 as well. The laboratory classifications are defined in the FDA Data Codes Manual.
5.10.6 Testing Results Obtained from Subcontractors
Subcontracting laboratories are not utilized by ORA laboratories, therefore, there is no such data found for incorporation in the analysis report to the customer.
5.10.7 Electronic Transmission of Results
In the case of transmission of test or calibration results by telephone, facsimile or other electronic means, such transmission is conducted under conditions that meet the criteria of Volume I, subsection 5.4.7 Control of Data.
5.10.8 Format of Worksheets
The format for laboratory worksheets is designed to accommodate the type of test conducted to minimize the possibility of misunderstanding or misuse. The worksheet format is described in Volume II, Section 2, ORA-LAB.5.10 Reporting Laboratory Data.
5.10.9 Amendments to Worksheet
Material amendments to analytical findings after issue are made only in the form of an additional document. They are flagged “Additional Analyses” in accordance with procedure ORA-LAB.5.10 Reporting Laboratory Data of Volume II. Amendments are to meet the same reporting criteria.
- Volume II, Section 2, ORA-LAB.5.10 Reporting Laboratory Data.
- FDA Regulatory Procedures Manual.