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ORA Laboratory Manual		 Document TOC

Laboratory Manual 2008 Edition Department of Health and Human Resources Food and Drug Administration Office of Regulatory Affairs Division of Field Science with images of FDA Badges and FDA Centennial 1906 through 2008.

Introduction

  • Approval Signature Page ( PDFPDF Icon, 48 kb)

Volume I ORA Laboratory Manual of Quality Policies

  • ORA Laboratory Manual of Quality Policies ( PDFPDF Icon, 381 kb)

Volume II    ISO 17025 ORA Laboratory Procedures

Section 1 – Management Requirements (Templates)

  • Organization (refer to Vol. I section 4.1; Org. charts) ( PDFPDF Icon, 381 kb)
    ORA-LAB.4.1
  • Quality System (refer to Vol. I section 4.2 ( PDFPDF Icon, 381 kb)
    ORA-LAB.4.2 (ORA LM of Quality Procedures)
  • Document Control and Management ( PDFPDF Icon, 169 kb)
    ORA-LAB.4.3
  • Request, Tenders, Contracts (refer to Vol. I section 4.4) ( PDFPDF Icon, 381 kb)
    ORA-LAB.4.4 (Review of Requests, Tenders and Contracts)
  • Subcontracting (not applicable to field labs)
  • Purchasing and Receipt ( PDFPDF Icon, 116 kb)
    ORA-LAB.4.6
  • Client Services (refer to Vol. I section 4.7 ( PDFPDF Icon, 381 kb)
    ISO 17025 Subclause 4.7
  • Complaints ( PDFPDF Icon, 80 kb)
    ORA-LAB.4.8
  • Control of Non-conforming Work ( PDFPDF Icon, 64 kb)
    ORA-LAB.4.9
  • Corrective Action Procedure ( PDFPDF Icon, 223 kb)
    ORA-LAB.4.11
  • Preventive Action Procedure ( PDFPDF Icon, 74 kb)
    ORA-LAB.4.12
  • Record and Data Management ( PDFPDF Icon, 115 kb)
    ORA-LAB.4.13
  • Audits ( PDFPDF Icon, 198 kb)
    ORA-LAB.4.14
  • Management Review ( PDFPDF Icon, 89 kb)
    ORA-LAB4.15

Section 2 – Technical Requirements

  • General N/A
  • Personnel :Training Procedure ( PDFPDF Icon, 144 kb)
    ORA-LAB.5.2
  • Facilities and Environmental Conditions (linked to Vol. III, sec. 2) ( PDFPDF Icon, 123 kb)
    ORA-LAB.5.3
  • Test Methods & Validation
  • Methods, Method Verification and Validation ( PDFPDF Icon, 143 kb)
    ORA-LAB.5.4.5
  • Estimation of Uncertainty of Measurement ( PDFPDF Icon, 90 kb)
    ORA-LAB.5.4.6
  • Equipment ( PDFPDF Icon, 188 kb)
    ORA-LAB.5.5
  • Instrument and Equipment Documentation and Records ( PDFPDF Icon, 100 kb)
    ORA-LAB.5.5.1
  • Measurement Traceability ( PDFPDF Icon, 107 kb)
    ORA-LAB.5.6
  • Sampling (not applicable to field labs)
  • Sample Management ( PDFPDF Icon, 113 kb)
    ORA-LAB.5.8
  • Assuring the Quality of Test Results ( PDFPDF Icon, 95 kb)
    ORA-LAB.5.9
  • Reporting Laboratory Data ( PDFPDF Icon, 139 kb)
    ORA-LAB.5.10

Volume III Laboratory Operations, Applications and Programs

  • Section 1 Environmental Health and Safety ( PDFPDF Icon, 118 kb)
  • Section 2 Chain of Custody – Sample Handling ( PDFPDF Icon, 119 kb)
  • Section 3 Recording of Results - Analyst’s Worksheet ( PDFPDF Icon, 183 kb)
  • Section 4 Basic Statistics and Presentation ( PDFPDF Icon, 346 kb)
  • Section 5 Analysts on Inspection ( PDFPDF Icon, 223 kb)
  • Section 6 ORA Method Development and Validation Program ( PDFPDF Icon, 92 kb)
  • Section 7 Private Laboratory Guidance ( PDFPDF Icon, 183 kb)
  • Section 8 Courtroom Testimony ( PDFPDF Icon, 91 kb)

Volume IV Laboratory Training (linked to ORA U)

  • Orientation and Training Levels( PDFPDF Icon, 114 kb)
  • Section 1 Laboratory Orientation
    Answer Key: Laboratory Orientation ( PDFPDF Icon, 276 kb)
  • Section 2 Microbiology
    Answer Key: Microbiology ( PDFPDF Icon, 471 kb)
  • Section 3 Drug Analysis
    Answer Key: Drug Analysis ( PDFPDF Icon, 435 kb)
  • Section 4 Microanalytical and Filth Analysis ( PDFPDF Icon, 591 kb)
  • Section 5 Pesticides Analysis
    Answer Key: Pesticides Analysis ( PDFPDF Icon, 124 kb)
  • Section 6 Elemental Analysis
    Answer Key: Elemental Analysis ( PDFPDF Icon, 92 kb)
  • Section 7 Mycotoxin Analysis
    Answer Key: Mycotoxin Analysis ( PDFPDF Icon, 152 kb)
  • Section 8 Sensory Analysis
    Answer Key: Sensory Analysis ( PDFPDF Icon, 94 kb)
  • Section 9 Seafood Chemistry
    Answer Key: Seafood Chemistry ( PDFPDF Icon, 164 kb)
  • Section 10 Food Standards & Additives
    Answer Key: Food Standards and Additives ( PDFPDF Icon, 262 kb)
  • Section 11 Nutrient Analysis
    Answer Key: Nutrient Analysis ( PDFPDF Icon, 820 kb)
  • Section 12 Radioactivity
    Answer Key: Radioactivity ( PDFPDF Icon, 97 kb)
  • Section 13 Engineering ( PDFPDF Icon, 93 kb)
  • Section 14 Consumer Complaints/Product Tampering ( PDFPDF Icon, 108 kb)

 

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)

 

Important disclaimer: The LM Adobe pdf by volumes/sections files provided represent a duplicate of the HARDCOPY LM content. Be aware that the pdf files have not been updated although these files may be updated in the future. The LM html version is the most current version.

 

PDF files may be viewed with the free Acrobat Reader software from Adobe. If you do not have Acrobat Reader installed on your computer, download an accessible version of the Adobe Acrobat Reader plugin for your browser at: http://www.adobe.com/products/acrobat/alternate.html by selecting the "Get Acrobat Reader" button below.

 

 

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