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U.S. Department of Health and Human Services

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Volume I - 4.6 Purchasing Services and Supplies

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ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

VERSION NO.:2.0

ORA Laboratory Manual of Quality Policies

EFFECTIVE DATE:
10-01-03
REVISED:
05-02-14

4.6.1 Procedure

The laboratory or designated purchasing agents use Federal Acquisition Regulations (FAR) and related procedures for the procurement of materials, supplies and services that critically affect the quality of the tests or calibrations. These procedures describe the process for the selection, purchase, reception and storage of equipment, services and supplies, including reagents and laboratory consumable materials, used in the performance of the tests and calibrations. Each laboratory has work instructions describing the processing of requisitions.

4.6.2 Inspection and Verification

The laboratory’s purchasing procedure describes how purchased equipment, supplies, services, reagents, and consumable materials that critically affect the quality of tests or calibrations are inspected or verified prior to use or concurrently with use. Inspection or verification criteria are used to establish conformance with requests made by the customer, included in standard specifications, or defined in the methods.

4.6.3 Purchasing Documents

Purchasing documents for items affecting the quality of laboratory output describe the services or supplies ordered. These purchasing documents are reviewed and approved for technical content prior to submission.

4.6.4 Records and Registry

Records of supplier evaluations and a list of approved suppliers are maintained by purchasers of laboratories equipment, services, and supplies.

Related Procedures

  • Government Accounting Office (GAO) Policy and Procedures Manual
  • SMG 2610 Procurement and Supply Management
  • Federal Acquisition Requirements 
  • Office of Management and Budget (OMB), General Service Administration (GSA), HHS, Federal Property Management Regulations (FPMR), FDA and ORA manuals, specific issuances
  • Public Law (PL) 95-507

Each ORA laboratory has its own purchasing procedure. A template is provided. See Volume II, Section I, ORA-LAB4.6 Purchasing Services and Supplies.