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Introduction
Approval Signature Page
Volume 1 ORA Laboratory Manual of Quality Policies
1.0 Introduction
2.0 Controlled Distribution of the Quality Manual
3.0 Quality Policy Statement
4.0 Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders and Contracts
4.5 Subcontracting of Tests
4.6 Purchasing Services and Supplies
4.7 Service to the Customer
4.8 Complaints
4.9 Control of Non-conforming Work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews
5.0 Technical Requirements
5.1 General
5.2 Personnel
5.3 Accommodation and Environmental Conditions
5.4 Test Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling Operations
5.8 Handling of Samples
5.9 Assuring the Quality of Test Results
5.10 Reporting the Results
6.0 Document/Change History
Volume 2 ISO 17025 ORA Laboratory Procedures
Section 1 - Management Requirements(Templates)
Organization (refer to Vol. I section 4.1; Org. charts) ORA-LAB.4.1
Quality System (refer to Vol. I section 4.2) ORA-LAB.4.2 (ORA LM of Quality Procedures)
Document Control and Management ORA-LAB.4.3
Request, Tenders, Contracts (refer to Vol. I section 4.4) ORA-LAB.4.4 (Review of Requests, Tenders and Contracts)
Subcontracting (not applicable to field labs)
Purchasing and Receipt ORA-LAB.4.6
Client Services (refer to Vol. I section 4.7) ISO 17025 Subclause 4.7
Complaints ORA-LAB.4.8
Control of Non-conforming Work ORA-LAB.4.9
Corrective Action Procedure ORA-LAB.4.11
Preventive Action Procedure ORA-LAB.4.12
Record and Data Management ORA-LAB.4.13
Audits ORA-LAB.4.14
Management Review ORA-LAB4.15
Section 2 - Technical Requirements
General N/A
Personnel: Training Procedure ORA-LAB.5.2
Facilities and Environmental Conditions (linked to Vol. III, sec. 2) ORA-LAB.5.3
Test Methods & Validation
Methods, Method Verification and Validation ORA-LAB.5.4.5
Estimation of Uncertainty of Measurement ORA-LAB.5.4.6
Equipment ORA-LAB.5.5
Instrument and Equipment Documentation and Records ORA-LAB.5.5.1
Measurement Traceability ORA-LAB.5.6
Sampling (not applicable to field labs)
Sample Management ORA-LAB.5.8
Assuring the Quality of Test Results ORA-LAB.5.9
Reporting Laboratory Data ORA-LAB.5.10
Volume 3 Laboratory Operations, Applications and Programs
Section 1 Environmental Health and Safety
1.1 Introduction
1.2 Laboratory Safety
1.3 Emergency Response
1.4 Environmental Health (EH)
1.5 Environmental Health & Safety Audit
1.6 Investigations Branch Activities & Safety
1.7 ORA Environmental Health and Safety References
Section 2 Chain of Custody -Sample Handling
2.1 Introduction
2.2 Protection, Storage, and Unique Identification of Samples in the Laboratory
2.3 Custodial Receipt and Storage of Samples
2.4 Receiving Samples from Custodial Storage and Opening the Sample Package
2.5 Intra/Inter Laboratory Splitting and Transferring of Samples
2.6 Preparing Reserve Samples for Storage or Shipment
2.7 Returning Samples to Custodial Storage
2.8 Shipping Samples from the Laboratory
2.9 Disposition of Samples
2.10 References
Section 3 Recording of Results - Analyst's Worksheet
3.1 Introduction
3.2 Recording Analytical Information, Observations and Findings
3.3 Completing Worksheet and Continuation Sheet
3.4 Additional and Check Analysis
3.5 Assembling, Reviewing, and Approving the Analytical Package
3.6 Abbreviated Recording and Reporting of Findings for Surveillance Samples
3.7 Consumer Complaint Letters
3.8 Definitions
3.9 Document/Change History
Section 4 Basic Statistics and Presentation
4.1 Introduction
4.2 General Considerations
4.3 Data Handling and Presentation
4.4 Linear Curve Fitting
4.5 Development and Validation of Spreadsheets for Calculation of Data
4.6 Control Charts
4.7 Statistics Applied to Drug Analysis
4.8 Statistics Applied to Radioactivity
4.9 Statistics Applied to Biological Assays
4.10 Statistics Applied to Microbiological Analysis
4.11 Document History
Section 5 Analysts on Inspection
5.1 Historical Background and the Law
5.2 Analysts on Inspection
5.3 Types of Inspections
5.4 Establishment Inspection Reports
5.5 FDA-483 Objectionable Conditions and Practices
5.6 TurboEIR
5.7 Computerized Systems and Electronic Records
5.8 Helpful References Pages on the Internet or Intranet
5.9 Document/Change History
Section 6 ORA Method Development and Validation Program
6.1 Introduction
6.2 Purpose
6.3 Background and Program Overview
6.4 Roles and Responsibilities
6.5 ORA Method Development and Validation Process
6.6 Scientific Conduct When Performing Research
6.7 Document/Change History
6.8 Appendices
Section 7 Private Laboratory Guidance
7.1 Objective
7.2 Sampling
7.3 Information about the Private Laboratories
7.4 Audit Samples
7.5 On-site Assessment Visits
7.6 Consultations
7.7 Meetings
7.8 Continuing Problems
7.9 Time Reporting
7.10 Requests for Referrals
7.11 Attachments
7.12 Document History
Section 8 Courtroom Testimony
8.1 Introduction
8.2 The Basics
8.3 Giving Testimony
8.4 The Scientific Witness
8.5 General References
8.6 Attachments
Volume 4 Laboratory Training
Orientation and Training Levels
Section 1 Laboratory Orientation
1.1 Introduction
1.2 FDA Laws and Regulations
1.3 Analytical Methods
1.4 The Sample
1.5 Additional Records
1.6 Other Information
1.7 General References
1.8 Orientation Exercises
1.9 Appendices
1.10 Document/Change History
Section 2 Microbiology
2.1 Introduction
2.2 Media, Reagent, and Supply Preparation
2.3 Safety and Hazardous/Infectious Waste
2.4 Quality Assurance
2.5 Food Pathogens and Indicator Organisms
2.6 Viruses
2.7 Select Agents
2.8 Alkaline Phosphatase
2.9 Polymerase Chain Reaction (PCR)
2.10 Pulsed Field Gel Electrophoresis (PFGE)
2.11 Canned Food and Can Seam Examination
2.12 Cosmetic Analysis
2.13 Sterility of Drugs and Medical Devices
2.14 Microbial Limits Test
2.15 Establishment Inspections
2.16 Appendix - Answer Key
2.17 Document/Change History
Section 3 Drug Analysis
3.1 Introduction
3.2 Historical Background and Law
3.3 Sources of Methodology
3.4 Pharmaceutical Chemistry
3.5 References
3.6 Appendices
3.7 Answer Key
3.8 Document/Change History
Section 4 Microanalytical and Filth Analysis
4.1 Introduction
4.2 General Information
4.3 Basic Techniques
4.4 Basic Analysis
4.5 Document/Change History
Section 5 Pesticides Analysis
5.1 Introduction
5.2 General Exercises
5.3 Gas Chromatography
5.4 Gas Chromatography, Selective Detectors
5.5 Quantification
5.6 Sample Analysis
5.7 Sample Results, Evaluation, and Reporting
5.8 Pesticide Residue Confirmation
5.9 Appendix - Answer Key
5.10 Document/Change History
Section 6 Elemental Analysis
6.1 Introduction
6.2 Exercises for Entry Level Analysts
6.3 Exercises for Experienced Analysts
6.4 References
6.5 Appendix – Answer Key
6.6 Document/Change History
Section 7 Mycotoxin Analysis
7.1 Introduction
7.2 Safety Precautions
7.3 Sample Preparation
7.4 Exercises
7.5 References
7.6 Appendix – Answer Key
7.7 Document/Change History
Section 8 Sensory Analysis
8.1 Introduction
8.2 Basic Considerations for Selecting Objective Sensory Analysts
8.3 Understanding of Terminology
8.4 Training
8.5 References
8.6 Appendix - Sensory Scale
8.7 Appendix - Answer Key
Section 9 Seafood Chemistry
9.1 Introduction
9.2 Chemical Indices of Decomposition [Basic]
9.3 Chemotherapeutics in Seafood
9.4 Seafood Toxins [Advanced]
9.5 Answer Key
Section 10 Food Standards and Additives
10.1 Food Standards
10.2 Food and Color Additives
10.3 Appendix – Answer Key
10.4 Document/Change History
Section 11 Nutrient Analysis
11.1 Introduction
11.2 Historical Background
11.3 Sources of Methodology
11.4 Nutrient Analysis
11.5 Appendix - Answer Key
11.6 Document History
Section 12 Radioactivity
12.1 Introduction
12.2 Radiation Safety
12.3 Laboratory Radiation Detection Instrumentation
12.4 Radionuclides in Foods Program
12.5 Radiopharmaceutical Program
12.6 Quality Assurance and Quality Control
12.7 Answer Key
Section 13 Engineering
13.1 Introduction
13.2 Photography
13.3 Basic Electricity
13.4 Electromagnetic Interference
13.5 Temperature
13.6 Relative Humidity
13.7 Mechanical Forces and Thickness
13.8 Pressure
13.9 Air Flow
13.10 Sound
13.11 Radiation
13.12 Instrumentation
13.13 Medical Device Standards
13.14 References
Section 14 Consumer Complaints and Product Tampering
14.1 Objective
14.2 Introduction
14.3 FDA Laws and Regulations
14.4 Preliminary Information and the Analytical Strategy
14.5 Safety
14.6 Sample Handling
14.7 Initial Observations
14.8 Analytical and Instrumental Methods
14.9 Analytical Documentation
14.10 Reporting
14.11 References
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