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ORA Laboratory Manual

Introduction

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

• Manual of Quality Policies for ORA Regulatory Laboratories

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
• Preventive Action - 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 Guidance
• Section 8 Courtroom Testimony

Volume IV - Laboratory Training (lined to ORA U)

• Orientation and Training Levels
• Section 1 Laboratory Orientation - Answer Key: Laboratory Orientation
• Section 2 Microbiology - Answer Key: Microbiology
• Section 3 Drug Chemistry Analysis
• Section 4 Microanalytical and Filth Analysis
• Section 5 Pesticides Analysis - Answer Key: Pesticides Analysis
• Section 6 Elemental Analysis - Answer Key: Elemental Analysis
• Section 7 Mycotoxin Analysis - Answer Key: Mycotoxin Analysis
• Section 8 Sensory Analysis - Answer Key: Sensory Analysis
• Section 9 Seafood Chemistry - Answer Key: Seafood Chemistry
• Section 10 Food Standards & Additives - Answer Key: Food Standards and Additives
• Section 11 Nutrient Analysis - Answer Key: Nutrient Analysis
• Section 12 Radioactivity - Answer Key: Radioactivity
• Section 13 Engineering
• Section 14 Consumer Complaints and Product Tampering
• Section 15 Drug and Device Microbiology
• Section 16 Tobacco Product Analysis

Change History & Contact

• Contact Information