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...............................................................8 

.................................................8 

.................................................8 

.................................................9 

8. Records .....................................................................

9. Supporting Documents ..............................................

10. Document History ......................................................

11. Change History........................................................................

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 1 of 9 

Sections in This Document 

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

2. Scope .......................................................................................................................................2 

3. Responsibility............................................................................................................................2 

4. Background...............................................................................................................................2 

5. References ...............................................................................................................................2 

6. Procedure .................................................................................................................................3 

6.1. Sample Receipt..............................................................................................................3 

6.1.1. Receipt of FDA Samples..................................................................................3 

6.1.2. Other (Non-FDA) Samples:..............................................................................3 

6.1.3. Samples Submitted for Storage Only:..............................................................3 

6.2. Sample Receipt and Processing:...................................................................................3 

6.3. Sample Storage .............................................................................................................5 

6.3.1. General ............................................................................................................5 

6.3.2. Sample Storage During Analysis .....................................................................6 

6.4. Sample Transfers...........................................................................................................6 

6.4.1. Within the Laboratory.......................................................................................6 

6.4.2. Outside of the Laboratory ................................................................................6 

6.4.3. Sample Reserve Portions ................................................................................7 

6.4.4. Sample Disposition ..........................................................................................7 

7. Glossary/ Definitions..................................................

.................................................9 

12. Attachments..............................................................................................................................9 

1. Purpose 

This procedure addresses the topics of sample receipt and processing, sample 

rejections, sample storage, sample transfers and analyst custody, sample 

shipping, and sample disposal. 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 2 of 9 

2. Scope 

ORS laboratories do not routinely collect samples outside the laboratory. Field 

collection requirements and sampling plans are outlined in the FDA 

Investigations Operations Manual (IOM). This procedure applies to sample 

handling after they are received in ORS laboratories 

3. Responsibility 

A. Laboratory Management 

1. Responsible for the overall control of samples in the Laboratory and 

ensuring personnel are trained in the proper handling, storage, 

accountability, and security of samples. 

B. Sample Custodians and Analysts 

1. Are responsible for documenting sample receipt, maintaining sample 

accountability in FACTS, storage, disposal or intra-laboratory 

transfers, and security of the samples within their areas. 

2. Sample Custodian personnel are responsible for the initial and final 

stages of sample storage and/or disposal. 

C. Compliance Officers 

1. Compliance Officers of the Compliance Branch for the collecting 

division are responsible for authorizing disposition of samples. In the 

case of non-FDA samples, the requesting or collecting organization 

authorizes disposition. 

4. Background 

None 

5. References 

A. FDA Investigations Operations Manual (IOM), current revision 

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

testing and calibration laboratories, section 7.4. 

C. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 3 of 9 

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

August 2018. 

D. FD&C Act Section 702(b) 

E. SOP-000285 Sample Feedback Report Process 

6. Procedure 

6.1. Sample Receipt 

6.1.1. Receipt of FDA Samples 

A. Samples for the analyzing laboratory are received in a designated area 

(i.e. sample processing room). 

B. Agency samples delivered to the laboratory must have an associated 

Collection Report (C/R) in the Field Accomplishments and Compliance 

Tracking System (FACTS). FACTS assigns, sequentially, a unique 

identification number which initiates sample tracking. Sample 

identification is described in the Investigations Operations Manual 

(IOM). 

6.1.2. Other (Non-FDA) Samples: 

For non-agency samples (e.g. State or USDA) delivered to the laboratory, 

unique identification and a corresponding Collection Report are generated in 

FACTS. The laboratory initiates sample tracking or accepts the sample in 

FACTS to assign the unique identification number for the sample. 

6.1.3. Samples Submitted for Storage Only: 

Samples from non-FDA agencies received for storage purposes only do not 

need to be entered into FACTS but are to be tracked using local procedures. 

The unique identifier would be the requesting or collecting agency’s 

identification. 

6.2. Sample Receipt and Processing: 

A. Upon receipt of the sample the sample custodian or alternate observes 

the general condition of the arriving packages containing samples. 

1. The sample custodian records the condition of the sample(s) and 

compares each sample with the C/R for the following items: 

collector, analyzing organization, number of units, collection date, 

sample identification number, matrix and product identification, 

requested analyses, and storage conditions. 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 4 of 9 

2. If a collection report and its samples are received and found to be 

incomplete the sample custodian notifies a supervisor or analyst. If 

possible, the person receiving the sample shipment or Supervisor 

will contact the collecting officer to resolve immediate discrepancies. 

3. Modifications or instructions are annotated in FACTS. 

4. If the sample ID does not match the sample ID on the collection 

report, the sample is held pending clarification from the collector. If 

clarification cannot be satisfactorily obtained, the samples are stored 

temporarily or returned. 

5. If the sample is rejected, the reason for rejection is documented in 

FACTS. The sample may be returned to the collector. 

6. Any records or documentation received with the sample (i.e. chain of 

custody forms from Office of Criminal Investigations) remain with the 

sample records throughout any transfers within the laboratory. 

B. The sample custodian verifies other information such as: 

1. If applicable, presence of seal and seal integrity (NOTE: Seals are 

not needed on all samples. See the IOM, Section 4 for sample 

identification requirements); 

2. Seal quotation, including date and signature or initials are consistent 

with electronic C/R; 

3. Analysis requested (If an analysis is not performed by the receiving 

lab, management is contacted, or local instructions are followed to 

forward the sample to the correct analyzing laboratory); and 

4. Shipping conditions are in accordance with sample 

environmental/storage requirements (If not, the supervisor is 

contacted for clarification). 

C. Sample condition and acceptability is checked and documented in 

FACTS 

D. The following criteria determine the acceptance or rejection of samples: 

1. physical condition of the sample container (e.g. visible damage, 

leakage, seals intact). If unacceptable, the collector is notified 

verbally or electronically by a Supervisor, analyst or Sample 

Custodian and the sample is classified as a Class 5. 

2. NOTE: If a sample is leaking, contain the leak and notify the local 

Industrial Hygienist or Supervisor in accordance with the laboratory’s 

local procedure. 

For the most current and official copy, check QMiS. 
 

 

 

 

 

 

 

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 5 of 9 

3. For loss of sample due to incomplete or improper sealing (e.g. 

leakage of liquids from bottles, loss of particulate material from 

containers and improper sealing of bags), the supervisor in the area 

of requested testing will consult with the collecting office to 

determine if any remaining sample can be salvaged for testing. If 

none of the sample can be salvaged it is classified as a Class 5. 

4. For samples that have been compromised (i.e. damaged, 

contaminated, or integrity questioned) the collecting office is notified 

verbally or electronically by management of the issue and consulted 

on the course of action to take. The sample is stored until further 

instructions are provided by laboratory management in conjunction 

with the collector in order to continue processing the sample. All 

communications are documented. 

E. Laboratory Management and/or the Quality System Manager are the 

authorizing officials to determine whether samples not meeting required 

criteria for testing are rejected. 

F. Acceptable samples are logged into FACTS. The following information 

at a minimum will be annotated: date received (FACTS field defaults to 

date entered), condition of container, shipping information, seal quotes, 

where (city and state), storage location, and any comments in the 

special handling instruction field. 

G. Perishable or urgent priority samples received will be processed first 

and the applicable section Supervisor or assigned analyst is notified. 

H. Sample issues, communications, and their resolution will be 

documented in accordance with SOP-000285 Sample Feedback Report 

Process. 

6.3. Sample Storage 

6.3.1. General 

Samples awaiting analyses are placed in storage locations designated and 

designed to protect the integrity of the sample. 

A. Samples are stored frozen, refrigerated or at room temperature in 

accordance with instructions received with the sample, Program 

requirements, or laboratory management. Controlled drug substances 

are stored in a separate locked area (i.e. safe) with limited access. 

B. The sample storage areas are designed to prevent contamination, cross 

contamination, or damage to the sample packaging and any seals. 

Each laboratory has a local procedure for monitoring the environmental 

conditions of sample storage areas. 

For the most current and official copy, check QMiS. 
 

 

 

 

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 6 of 9 

6.3.2. Sample Storage During Analysis 

A. Samples are kept in locked/limited access areas while in the analyst’s 

possession. 

B. If limited access storage is not available or practical within the testing 

lab area(s), the sample is returned to the Sample Custodian. 

6.4. Sample Transfers 

6.4.1. Within the Laboratory 

A. Chain of Custody for sample transfers between the Sample Custodian 

and analysts are recorded in FACTS and documented on the analytical 

worksheet 

B. Samples transferred between analysts are documented on the 

analytical worksheet and in FACTS. 

C. When the splitting of samples within the laboratory is needed (i.e. a 

sample that requires an analysis by two or more different work areas), it 

is accomplished by performing the “In-House Split” operation within 

FACTS and creating an assignment in FACTS. 

D. Reserve portions of all samples are returned to the Sample Custodian 

unless documented otherwise on the analytical worksheet and in 

FACTS. 

6.4.2. Outside of the Laboratory 

A. Samples are shipped to ensure sample integrity and condition. 

B. Samples or portions of samples transferred outside the laboratory are 

entered and accomplished in FACTS. A sample, that requires a portion 

to be sent elsewhere must be documented in FACTS by performing 

the “Sample Split” operation. 

C. The following information is documented for all samples or portions 

shipped: (1) what was provided and how much, (2) how it was prepared 

for delivery, (3) how it was identified and sealed, (4) a brief explanation 

as to why the sample or portion was sent, (5) to whom the sample or 

portion was sent, and (6) the date of shipment. 

D. For samples that are split between FDA/ORA laboratories, each 

examining laboratory handles and describes its portion of the sample as 

though it were an original analysis. 

For the most current and official copy, check QMiS. 
 

 

 

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 7 of 9 

6.4.3. Sample Reserve Portions 

A. Sample reserves are prepared and returned to the Sample Custodian 

upon completion of the analysis for storage or shipment and 

documented on the worksheet and in FACTS. 

B. The Sample Custodian stores the reserve in the designated storage 

area and under proper storage conditions that ensures its integrity. 

C. If sample is depleted during analytical processes, this is recorded on the 

worksheet and in FACTS. 

6.4.4. Sample Disposition 

A. Samples are disposed of in accordance with Federal, State and local 

regulations. 

B. Authorization to dispose samples comes from the Compliance Officer, 

the Laboratory Director, or designated laboratory personnel through the 

FACTS-Sample Disposition Notice (SDN). Under certain circumstance 

in accordance with the laboratory procedure, the analyst may dispose of 

a sample. In FACTS, this is an in-house disposition of the sample 

reserve. 

C. If the in-house disposition is used, a local procedure or program specific 

requirements is used to determine what circumstances and conditions 

the analyst may destroy the reserve. Examples where reserve samples 

may be destroyed by the analyst are: 

1. no reserve sample remains because the entire sample was 

consumed during analysis, 

2. the reserve is an import product with no action indicated (NAI) 

classification or 

3. perishable samples with NAI classification where the Supervisor has 

concurred with immediate destruction. 

D. The analyst documents the in-house destruction of the reserve sample 

in FACTS. 

E. Disposition of the sample is completed in a timely manner following 

receipt of the disposition authorization in FACTS or by memorandum. 

Date of disposal is documented in FACTS. 

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FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 8 of 9 

7. Glossary/ Definitions 

A. FACTS - The Field Accomplishments and Compliance Tracking System 

(FACTS) is FDA’s national operational database used to manage field 

work assignments, and record work results from assignment through 

compliance action. 

B. Sample accountability – This is a continuous record providing objective 

evidence that the sample's integrity has been preserved and 

demonstrates continuity of handling and chain of custody. 

8. Records 

A. Collection Report 

B. FDA Official Seal 

C. Analyst Worksheet 

D. Electronic records, such as FACTS 

E. Sample Feedback Report form 

9. Supporting Documents 

Local sample storage area work instructions 

ORA Laboratory Manual, Volume III, Section 2, Chain of Custody – Sample 

Handling. 

For the most current and official copy, check QMiS. 
 

 

 

 

 

 

 

FOOD AND DRUG ADMINISTRATION 

OFFICE OF REGULATORY AFFAIRS 

ORA Laboratory Manual Volume II 

Document Number: 

ORA-LAB.5.8 

Revision #: 02 

Revision Date: 

06/06/2019 

Title: 

Sample Management Page 9 of 9 

10. Document History 

Revision 

# 

Status* 

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

1.2 R 11/16/05 LMEB LMEB 

1.3 R 08/15/08 LMEB LMEB 

1.4 R 01/11/11 LMEB LMEB 

1.5 R 05/08/14 LMEB LMEB 

02 R 06/06/2019 LMEB LMEB 

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

11. Change History 

Revision 

# Change 

1.2 In Document 

1.3 In Document 

1.4 In Document 

1.5 In Document 

02 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. 

12. Attachments 

None 

For the most current and official copy, check QMiS.