Standard for Internal Validation of Forensic 

DNA Analysis Methods

Standard for Internal 

Validation of Forensic DNA 

Analysis Methods

Biological Methods Subcommittee

Biology/DNA Scientific Area Committee

Organization of Scientific Area Committees (OSAC) for Forensic Science
Standard for Internal Validation of Forensic 

DNA Analysis Methods

OSAC Proposed Standard

Standard for Internal Validation of 

Forensic DNA Analysis Methods

Prepared by

Biological Methods Subcommittee

Version: 1.0

Disclaimer:

This document has been developed by the Biological Methods Subcommittee of the Organization of 

Scientific Area Committees (OSAC) for Forensic Science through a consensus process and is 

proposed for further development through a Standard Developing Organization (SDO). This document

is being made available so that the forensic science community and interested parties can consider the 

recommendations of the OSAC pertaining to applicable forensic science practices. The document was 

developed with input from experts in a broad array of forensic science disciplines as well as scientific 

research, measurement science, statistics, law, and policy. 

This document has not been published by an SDO. Its contents are subject to change during the 

standards development process. All interested groups or individuals are strongly encouraged to submit 

comments on this proposed document during the open comment period administered by the American 

Academy of Forensic Science Standards Board (www.asbstandardsboard.org). 
Standard for Internal Validation of Forensic 

DNA Analysis Methods

Table of Contents

1. SCOPE..................................................................................................................................................5

2. NORMATIVE REFERENCES...........................................................................................................3

3. TERMS and DEFINITIONS ............................................................................................................3

4. REQUIREMENTS..............................................................................................................................4

5. ANNEX.................................................................................................................................................6
Standard for Internal Validation of Forensic 

DNA Analysis Methods

1. SCOPE

This document details general requirements for performing an internal validation of all 

forensic DNA analysis methods within a forensic DNA laboratory.

2. NORMATIVE REFERENCES

The following referenced documents are the foundation of these best practices. For dated 

references, only the edition cited applies. For undated references, the latest edition of the 

referenced document applies.

ENSFI. Recommended Minimum Criteria for the Validation of Various Aspects of the DNA 

Profiling Process. 

http://www.enfsi.eu/sites/default/files/documents/minimum_validation_guidelines_in_d

na_profiling_-_v2010_0.pdf

SWGDAM. SWGDAM Validation Guidelines for Forensic DNA Analysis Methods.

https://www.swgdam.org/#!publications/c1mix

3. TERMS and DEFINITIONS

3.1 Contamination is exogenous DNA or other biological material in a DNA sample, 

PCR reaction, or item of evidence.

3.2 Developmental validation is the acquisition of test data and determination of 

conditions and limitations of a new methodology.

3.3 DNA Analysis is the use of DNA technologies for the evaluation of biological 

evidence that may be involved in legal matters.

3.4 Internal Validation is the accumulation of test data within the laboratory for 

developing the laboratory standard operating procedures and demonstrating that 

the established protocols for the technical steps of the test and for data 

interpretation perform as expected in the laboratory.

3.5 Precision is the degree of mutual agreement among a series ofindividual 

measurements, values and/or results.

3.6 Sensitivity studies are a set of critical studies performed during developmental 

and/or internal validation of DNA or other test methods designed to define the 

lower and upper limits/ bounds of an assay to accurately detect ananalyte.

3.7 Validation is the process of performing and evaluating a set of experiments that 

establish the efficacy, reliability, and limitations of a method, procedure or 

modification thereof; establishing recorded documentation that provides a high
Standard for Internal Validation of Forensic 

DNA Analysis Methods

degree of assurance that a specific process will consistently produce an outcome 

meeting its predetermined specifications and quality attributes.

4. REQUIREMENTS

4.1 The laboratory shall conduct internal validation studies on all forensicDNA 

analysis methodologies prior to use on casework or database samples.

4.2 The laboratory shall conduct additional internal validation studies if an alteration 

that has the potential to influence results is made to a validated forensic DNA 

analysis methodology.

4.3 Internal validation studies shall be documented to include, at a minimum,a 

summary of all testing results and conclusions, raw data, and statistical 

calculations (if applicable) used to support conclusions.

4.4 Quality assurance parameters, interpretation guidelines, and analytical 

procedures shall be derived from internal validation studies.

4.4.1 Information from developmental validation studies and internal 

validation studies from other forensic laboratories may be utilized, 

if made available for review.

4.5 Developmental validation studies may be used to satisfy applicable elements of 

the internal validation standards if the laboratory conducted or participated in 

developmental validation of the methodology.

4.6 Results from internal validation studies that contradict developmental validation 

shall be investigated. A statement of explanation for the contradiction shall be 

included in the final internal validation document if the data are accepted for 

analytical procedure development.

4.7 Results from internal validation studies that fall outside the scope of 

developmental validation shall be included in the final internalvalidation 

document if the data are utilized for analytical proceduredevelopment.

4.8 Where methodology specific internal validation standards exist, if a required 

study is determined to be not applicable, an explanation shall be provided in the 

final internal validation document.

4.9 Each laboratory within a multi-laboratory system shall conduct applicable 

internal validation studies impacted by location-specific factors (precision, 

sensitivity, susceptibility to contamination, etc.).

4.9.1 Internal validation studies that are not location-specific may be 

shared among laboratories within the system, if made availablefor 

review.
Standard for Internal Validation of Forensic 

DNA Analysis Methods

4.10 Internal validation studies shall be approved by the DNA Technical Leader prior 

to implementation of the methodology for casework or database applications. 

Approval shall be documented by the Technical Leader, at a minimum, with 

initials and the date of review.

5. CONFORMANCE

In order to demonstrate conformance with this standard, the laboratory shall have the 

following:

5.1 Documented internal validation studies and any alterations on all forensic DNA 

analysis methodologies intended for forensic casework or database applications 

prior to implementation.

5.2 Quality assurance parameters, interpretation guidelines, and analytical 

procedures derived from internal validation studies.

5.3 Documented approval by the DNA Technical Leader prior to implementation.

6. ANNEX

Annex A – Foundational Principles

None

Annex B – Bibliography

Butler, J.M. Quality Assurance and Validation. In: Advanced Topics in Forensic DNA Typing: 

Methodology. Elsevier, 2011

FBI, Quality Assurance Standards for DNA Databasing Laboratories.

https://www.swgdam.org/#!publications/c1mix

FBI, Quality Assurance Standards for Forensic DNA Testing Laboratories.

https://www.swgdam.org/#!publications/c1mix