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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 1 of 7 

Sections in This Document 

Purpose ................................................................................................................................. 1 

Scope .................................................................................................................................... 1 

Responsibility ........................................................................................................................ 2 

Background ........................................................................................................................... 2 

References ............................................................................................................................ 3 

Procedure.............................................................................................................................. 3 

Glossary/Definitions............................................................................................................... 6 

Records ................................................................................................................................. 6 

Supporting Documents .......................................................................................................... 7 

Document History .................................................................................................................. 7 

Change History...................................................................................................................... 7 

Attachments........................................................................................................................... 7 

Purpose 

This procedure provides policies and instructions for procurement of supplies, 

materials, equipment, and services that affect the quality of laboratory 

activities. 

Scope 

This procedure applies to activities handled by personnel who request and 

purchase services and goods within the Office of Regulatory Science (ORS) 

laboratories. 

In addition to Federal laws pertaining to purchasing, quality system 

accreditation requires the laboratory evaluate suppliers of critical 

consumables, supplies and services which affect the quality of laboratory 

activities, and maintain records of these evaluations. This document’s focus is 

on those quality system requirements. 

For the most current and official copy, check QMiS. 
 

 

 

3. 

4. 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 2 of 7 

Responsibility 

A. Requestor 

Initiates request for services and supplies. Ensures critical specifications 

and requirements are provided. Ensures vendor is on the laboratory’s 

approved vendor list. 

B. Laboratory Management 

1. Reviews and approves purchase request for technical content and 

bona fide need. 

2. Ensure requirements and criteria for evaluation of externally 

provided products and services are defined. 

3. Ensures performance of external providers are evaluated and 

monitored. 

4. Ensures actions are taken, when relevant, arising from evaluations 

C. Quality System Manager (QSM): 

1. Ensures laboratory’s approved vendor list is maintained.

2. Ensures records of evaluation and monitoring activities of external 

providers are maintained. 

D. Division of Contracts and Grants (DFG) 

1. Ensures procurement of materials, supplies and services in 

accordance with FDA acquisition procedures and guidelines. 

2. Assists laboratory personnel in following agency procurement 

guidelines and requirements. 

3. Ensures that records of purchasing activities are retained as 

required. 

Background 

FDA requires use of Government Purchase Cards (GPC) and The Unified 

Financial Management System (UFMS) which incorporates iProcurement for 

purchase requisitions and the Purchase Request Information System (PRISM) 

for purchasing completed by administrative purchasing agents. 

For the most current and official copy, check QMiS. 
 

 

 

 

5. 

6. 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 3 of 7 

Requests for purchase of services and supplies directly related to the quality 

assurance program are preceded with a vendor and product review for 

compliance to specified requirements defined in the test methods and quality 

specific standards. Records of actions taken to check compliance shall be 

maintained. 

References 

A. ISO/IEC 17025:2017 General requirements for the competence of 

testing and calibration laboratories. Section 6.6. 

B. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018. 

C. ISO 17034:2016 or Guide 34 General Requirements for the 

Competence of Reference Material Producers 

D. SOP-000048 ORA Programmatic vs. Geographical Expenses 

E. SOP-000194 ORA Acquisition and Planning 

F. SOP-000204 ORA Purchase Card (PCARD) 

Procedure 

Laboratories shall adhere to both agency and accreditation requirements on 

purchasing, receipt, and management of externally provided products and 

services. 

6.1. Agency Policies and Requirements 

Laboratories follow agency policy and procedures for the purchase of products 

and services. 

Laboratory management should consult with DFG staff on matters of 

purchasing to ensure current agency requirements are being met. 

Local work instructions may be written to outline the process for procurement, 

receipt, and management of procurement records. 

6.2. Laboratory Accreditation Requirements 

Laboratories shall ensure that externally provided products and services that 

affect laboratory activities are suitable. 

For the most current and official copy, check QMiS. 
 

 

 

 

 

 

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 4 of 7 

Examples of products include measurement standards and equipment, 

auxiliary equipment, consumable materials, reference materials, etc. 

Examples of services include calibration services, testing services, facility and 

equipment maintenance services, proficiency testing services, assessment 

and auditing services, etc. 

6.2.1. Procurement 

Laboratories follow agency procedures for procurement. Product and service 

criteria are communicated to vendors through the purchasing request 

processes. 

6.2.2. Selection of Vendors 

A. Vendors are initially evaluated and selected based on the ability to meet 

contract conditions and quality system criteria. Additionally, vendors are 

selected in accordance with agency requirements and policies. 

However, vendors may be requested due to specifications in methods 

being used, experience with vendor, and cost. 

B. Products and services are purchased from approved vendors with an 

acceptable rating. 

C. Laboratories define local processes for rating suppliers and vendors as 

acceptable or not acceptable based on the level of service provided and 

any required accreditation or certifications held. A vendor is considered 

unacceptable and is not used when the quality of product or service 

does not meet expectations or specifications. 

D. Vendor approval shall be summarized for example on a vendor list and 

maintained by each laboratory. The vendor approval shall be reviewed 

and updated periodically according to a schedule and responsibility 

determined by the laboratory. 

E. Vendors of calibration services and reference materials shall meet 

traceability requirements in MAN-000041 ORA-LAB.5.6 Traceability. 

6.2.3. Monitoring and Re-evaluation of Vendors 

For the most current and official copy, check QMiS. 
 

 

 

 

 

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 5 of 7 

A. The performance level and accreditation status (when required) of 

routinely used vendors are monitored over time to ensure an acceptable 

level of service is maintained. For example: a laboratory may track 

instances of incorrect orders received, product quality issues, recalls, 

and other unsatisfactory events, and determination on suitability for 

continued use of the vendor. 

B. Minimum evaluation criteria include (where applicable): 

1. Does vendor’s continued use meet agency requirements?

2. Does vendor meet product/service specification and delivery 

schedule? 

3. Does vendor have consistently good service and product 

performance? 

4. How is vendor’s customer service and response to addressing 

problems? 

5. Is vendor accredited when required? 

C. Documentation of this evaluation and the outcome shall be maintained 

by the laboratory. 

6.2.4. Receiving, Inspecting, and Disbursing of Materials 

A. The laboratory shall ensure that purchased supplies, reagents, 

consumable materials, and services that affect the quality of tests 

and/or calibrations are not used until they have been inspected or 

otherwise verified as complying with standard specifications or 

requirements defined in the methods for the test and/or calibrations 

concerned. 

B. These services and supplies used shall comply with specified 

requirements. 

C. When materials and supplies are delivered and received, they are 

signed for by the designated individual with date of receipt and initials 

annotated on the receiving records and containers. 

D. Materials and supplies received are inventoried and verified against the 

original purchase order for completeness. 

E. If a discrepancy is found that could affect the product quality the 

material is either discarded or returned to the vendor. 

For the most current and official copy, check QMiS. 
 

 

 

7. 

8. 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 6 of 7 

F. Records of unsatisfactory materials and supplies and their disposition 

are maintained by the laboratory. These records establish trends in 

vendor performance and ensure that continuing quality material is 

accepted. 

6.2.5. Purchasing and Receipt Records 

Laboratories shall retain records for the following: 

A. Purchasing records; 

B. Vendor evaluation, selection, monitoring, and re-evaluation; 

C. Verification that received products and services meet the laboratory’s 

requirements; and 

D. Actions taken following vendor evaluation, monitoring, or re-evaluation. 

Glossary/Definitions 

A. Contract – This is the agreed terms between a supplier and customer 

transmitted by any means. 

B. Corrective action – This is action taken to eliminate the causes of an 

existing nonconformity, defect, or other undesirable situation to prevent 

recurrence. 

C. Non-conformity – This is the non-fulfillment of a contract term or 

condition. 

D. Material – This refers to hardware, software media, raw materials or 

components used in the development or testing of products. 

E. Supplies – This is the inventory needed to perform the work processes 

of an organization. 

F. Vendor/Supplier: Vendor and supplier are used interchangeably for an 

entity from which the laboratory procures items or services that could 

affect laboratory activities. 

Records 

A. Agency-required purchasing records 

B. Receiving records including packing slips 

C. Vendor evaluation 

For the most current and official copy, check QMiS. 
 

 

 

 

 

 

 

 

 

 

 

 

9. 

10. 

11. 

12. 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

Office of Regulatory Science 

Document Number: 

MAN-000027 

Revision #: 03 

Revised: 

2 August 2023 

Title: 

ORA Lab Manual Vol. II - Purchasing and Receipt (ORA-LAB.4.6) Page 7 of 7 

D. Records of unsatisfactory materials, supplies, services, and actions 

taken 

Supporting Documents 

MAN-000041 ORA Laboratory Manual, Volume II, ORA-LAB.5.6 

Traceability 

Document History 

Revision 

# 

Status* 

(D, I, R) Date Author Name and Title Approving Official Name and Title 

1.3 R 11/16/05 LMEB LMEB 

1.4 R 12/31/07 LMEB LMEB 

1.5 R 08/15/08 LMEB LMEB 

02 R 06/06/2019 LMEB LMEB 

03 R See QMiS LMEB LMEB 

* - D: Draft, I: Initial, R: Revision 

Change History 

Revision 

# Change 

02 

Added use of ISO Guide 34 vendors when possible; added “services” as appropriate 

where “product” is mentioned; clarified requirements for products/services related to 

quality processes; added items to Records section; refocused procedure on 

accreditation requirements; took out specifics on agency requirements and required 

lab management to consult with DFA for agency procurement requirements. 

Other revisions made as needed to align this procedure with new ISO/IEC 17025 and 

AOAC requirements. Revision to formatting and policy clarifications were also made. 

03 

Minor change of “Division of Field Administration (DFA) to Division of Contracts and Grants 

(DFG) due to most recent ORA realignment and addition of Document ID for MAN-000041. 

No other changes made to document. 

Attachments 

None 

For the most current and official copy, check QMiS.