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          Field Science - Laboratory ManualField Science and Laboratories Field Science - Laboratory Manual
  	
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Lab Manual Cover

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 LaboratoriesVolume 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-LAB4.15Volume 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.5.10Volume 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 TestimonyVolume 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 AnalysisContact

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

                                                                                  Content current as of:
      12/12/2023
                  
                   
Regulated Product(s)
		 Animal & Veterinary
			  			     			  			     Biologics
			     			  			     Cosmetics
			     			  			     Dietary Supplements
			     			  			     Drugs
			     			  			     Food & Beverages
			     			  			     Medical Devices
			     			  			     Radiation-Emitting Products
			     			  			     Tobacco
			     			  						              
			
			
			
			
			
						  Food & Color AdditivesField Science - Laboratory Manual
 
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