Field Science - Laboratory Manual

The Laboratory Manual is a reference manual for ORA laboratory personnel and supporting units. It provides personnel with information on internal policies and procedures to be used for testing consumer products, training laboratory staff, writing reports, safety, research, review of private laboratory reports, court testimony, and other laboratory activities. (Formerly: Laboratory Procedure Manual)

The ORA Laboratory Manual is approved by the Director of the Office of Regulatory Science, the Deputy, or a designee. Approval records are maintained on file.

Volume I - Manual of Quality Policies (ISO 17025 Requirements

Volume II - Management System Policies and Procedures

Document Control and Management - ORA-LAB.4.3
Purchasing and Receipt - ORA-LAB.4.6
Complaints and Feedback - ORA-LAB.4.8
Control of Nonconforming Work - ORA-LAB.4.9
Corrective Action - ORA-LAB.4.11
Risk Assessment and Improvement - ORA-LAB.4.12
Record and Data Management - ORA-LAB.4.13
Audits - ORA-LAB.4.14
Management Review - ORA-LAB4.15

Volume II - Technical Policies and Procedures

Personnel Training and Competency Management - ORA-LAB.5.2
Facilities and Environmental Conditions - ORA-LAB.5.3
Methods, Method Verification and Validation - ORA-LAB.5.4.5
Estimation of Measurement Uncertainty - ORA-LAB.5.4.6
Equipment - ORA-LAB.5.5
Equipment Records - ORA-LAB.5.5.1
Traceability - ORA-LAB.5.6
Sample Management - ORA-LAB.5.8
Ensuring the Quality of Test Results - ORA-LAB.5.9
Reporting Laboratory Results - ORA-LAB.5.10

Volume III - Laboratory Operations, Applications and Programs

Section 1 Environmental Health and Safety
Section 2 Chain of Custody - Sample Handling
Section 3 Recording of Results - Analyst's Worksheet
Section 4 Basic Statistics and Presentation
Section 5 Analysts on Inspection
Section 6 ORS Method Development and Validation Program
Section 7 Private Laboratory Analytical Packages
Section 8 Courtroom Testimony

Volume IV - Laboratory Training

Section 1 Laboratory Orientation
Section 2 Food and Feed Microbiology
Section 3 Drug Chemistry Analysis
Section 4 Microanalytical and Filth Analysis
Section 5 Pesticides Analysis
Section 6 Elemental Analysis
Section 7 Mycotoxin Analysis
Section 8 Sensory Analysis
Section 9 Seafood Chemistry
Section 10 Food Standards & Additives
Section 11 Nutrient Analysis
Section 12 Radiation Safety and Radioactive Material Analysis in the Laboratory
Section 13 Engineering
Section 14 Consumer Complaints and Product Tampering
Section 15 Drug and Device Microbiology
Section 16 Tobacco Product Analysis

Contact

For assistive needs regarding these documents please contact: ORALABManualEditorialBoard@fda.hhs.gov

Content current as of:

Regulated Product(s)

Animal & Veterinary
Biologics
Cosmetics
Dietary Supplements
Drugs
Food & Beverages
Medical Devices
Radiation-Emitting Products
Tobacco
Food & Color Additives