The DNA Identification Act of 1994 required the FBI laboratory to ensure that all DNA laboratories who receive federal grant funding or who participate in the National DNA Index System (NDIS) establish and maintain conformance with the FBI’s Quality Assurance Standards (QAS).
ANAB has a Memorandum of Understanding with the FBI allowing ANAB to perform external QAS audits using the FBI Quality Assurance Standards (QAS) Audit for Forensic DNA Testing Laboratories and the FBI Quality Assurance Standards (QAS) Audit for Forensic DNA Databasing Laboratories. By participating in a QAS Audit, both public and private DNA laboratories are ensuring they are meeting the QAS Audit Document standards.
What Is the ANAB QAS Audit Process?
QAS audit requirements are in addition to the ISO/IEC 17025:2017 and AR 3125 requirements assessed during an ANAB activity. ANAB can also perform stand-alone QAS audits, independent of any ANAB assessment activity. When done in conjunction with a 17025:2017 assessment, the QAS audits include additional standards for a DNA Technical Leader, CODIS Administrator, validation, proficiency testing, and outsourcing (i.e., contracting).
Also, an analyst’s education and training are memorialized within the actual QAS document which indicates their education and training have met the QAS standards. Any new training is listed in the document as well as meeting the QAS standards. DNA Analysts, Technical Leaders, and CODIS Administrators are required to be memorialized in two separate external QAS Audits, which are approximately two years apart. Validations are also memorialized in the QAS document and listed as meeting the QAS standards.
Any QAS Standard receiving a “No” during an ANAB assessment activity is tied to a subsequent ISO/IEC 17025:2017 and/or an AR 3125 (2023) requirement. This ensures the “No” finding will follow the nonconformance resolution process.
How Often Are QAS Audits Conducted?
An external QAS audit is approximately every two years, with an internal QAS audit being performed in the subsequent years. Some laboratories do choose to have an external QAS audit each year rather than every other year. The requirements in the QAS audit document are designed to ensure the quality and integrity of the data generated and uploaded to NDIS.
Learn more about ISO/IEC 17025 Forensic Testing Laboratory Accreditation here.