Science & Research
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Field Science
ORA Laboratory Manual
The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and court testimony. (Formerly: Laboratory Procedure Manual)
We have recently redesigned the FDA Web Site. As a result, some Web links (URLs) embedded within the manual are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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Volume I ORA Laboratory Manual of Quality Policies
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Volume II ISO 17025 ORA Laboratory Procedures: Section 1 – Management Requirements (Templates)
Organization (refer to Vol. I section 4.1; Org. charts) ORA-LAB.4.1 (PDF - 331KB)Quality System (refer to Vol. I section 4.2 - ORA-LAB.4.2 (ORA LM of Quality Procedures) (PDF - 331KB)Document Control and Management - ORA-LAB.4.3 (PDF - 110KB)Request, Tenders, Contracts (refer to Vol. I section 4.4) - ORA-LAB.4.4 (Review of Requests, Tenders and Contracts) (PDF - 331KB)Subcontracting Purchasing and Receipt - ORA-LAB.4.6 (PDF - 88KB)Client Services (refer to Vol. I section 4.7 - ISO 17025 Subclause 4.7 (PDF - 331KB)Complaints - ORA-LAB.4.8 (PDF - 144KB)Control of Non-conforming Work - ORA-LAB.4.9 (PDF - 40KB)Corrective Action Procedure - ORA-LAB.4.11 (PDF - 86KB)Preventive Action Procedure - ORA-LAB.4.12 (PDF - 46KB)Record and Data Management - ORA-LAB.4.13 (PDF - 101KB)Audits - ORA-LAB.4.14 (PDF - 125KB)Management Review - ORA-LAB4.15 (PDF - 153KB)
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Volume II ISO 17025 ORA Laboratory Procedures: Section 2 – Technical Requirements
General Personnel :Training Procedure - ORA-LAB.5.2 (PDF - 130KB)Facilities and Environmental Conditions (linked to Vol. III, sec. 2) - ORA-LAB.5.3 (PDF - 91KB)Test Methods & Validation Methods, Method Verification and Validation - ORA-LAB.5.4.5 (PDF - 532KB)Estimation of Uncertainty of Measurement - ORA-LAB.5.4.6 (PDF - 68KB)Equipment - ORA-LAB.5.5 (PDF - 149KB)Instrument and Equipment Documentation and Records - ORA-LAB.5.5.1 (PDF - 66KB)Measurement Traceability - ORA-LAB.5.6 (PDF - 69KB)Sampling Sample Management - ORA-LAB.5.8 (PDF - 115KB)Assuring the Quality of Test Results - ORA-LAB.5.9 (PDF - 131KB)Reporting Laboratory Data - ORA-LAB.5.10 (PDF - 250KB)
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Volume III Laboratory Operations, Applications and Programs
Section 1 Environmental Health and Safety (PDF - 86KB)Section 2 Chain of Custody – Sample Handling (PDF - 90KB)Section 3 Recording of Results - Analyst’s Worksheet (PDF - 161KB)Section 4 Basic Statistics and Presentation (PDF - 284KB)Section 5 Analysts on Inspection (PDF - 187KB)Section 6 ORA Method Development and Validation Program (PDF - 158KB)Section 7 Private Laboratory Guidance (PDF - 112KB)Section 8 Courtroom Testimony (PDF - 43KB)
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Volume IV Laboratory Training (linked to ORA U)
Orientation and Training Levels (PDF - 109KB)Section 1 Laboratory Orientation - Answer Key: Laboratory Orientation (PDF - 252KB)Section 2 Microbiology - Answer Key: Microbiology (PDF - 361KB)Section 3 Drug Analysis - Answer Key: Drug Analysis (PDF - 298KB)Section 4 Microanalytical and Filth Analysis (PDF - 465KB)Section 5 Pesticides Analysis - Answer Key: Pesticides Analysis (PDF - 167KB)Section 6 Elemental Analysis - Answer Key: Elemental Analysis (PDF - 82KB)Section 7 Mycotoxin Analysis - Answer Key: Mycotoxin Analysis (PDF - 113KB)Section 8 Sensory Analysis - Answer Key: Sensory Analysis (PDF - 68KB)Section 9 Seafood Chemistry - Answer Key: Seafood Chemistry (PDF - 176KB)Section 10 Food Standards & Additives - Answer Key: Food Standards and Additives (PDF - 193KB)Section 11 Nutrient Analysis - Answer Key: Nutrient Analysis (PDF - 208KB)Section 12 Radioactivity - Answer Key: Radioactivity (PDF - 64KB)Section 13 Engineering (PDF - 100KB)Section 14 Consumer Complaints/Product Tampering (PDF - 75KB)
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