10.51.05.06

.06 Calibration — General.

A. A licensee shall develop, establish, implement, maintain, and follow calibration procedures.

(1) If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensure that:

(a) Computer software is performance checked after updates occur or validated;

(b) Procedures are established, maintained, and followed to protect and secure the data; and

(c) Computers and automated equipment are maintained to ensure proper functioning.

(2) A licensee shall ensure that:

(a) Reference standards are calibrated by an entity that can provide traceability;

(b) Measuring devices including rulers, weights, pipettes, balances, thermometers, and other devices that affect a forensic analysis result are calibrated against a reference standard traceable to the International System of Units, if available, as required by the manufacturer or forensic laboratory’s quality assurance program;

(c) Calibration, if applicable, is performed:

(i) Before initial use and before the recalibrated item is returned to service;

(ii) Following service or maintenance; and

(iii) At intervals specified by the manufacturer or more frequently as determined by the technical leader or quality assurance manager; and

(d) All calibration activities are documented.

B. Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall:

(1) Include in the method calibration:

(a) A sufficient number of calibrators and quality control samples in each batch that are consistent with the analysis being performed; and

(b) Analyses being performed on unusual specimens that:

(i) Use appropriate matrix-matched calibrators, when possible; and

(ii) Are prepared and tested concurrently with the specimen; and

(2) Have a policy that defines a specimen that has a unique matrix.