MS-QA_06-2019 rev5

ANSI/AARST MS-QA 2019 23 Radon Measurement Systems Quality Assurance Laboratories—All Methods 7 LABORATORY REQUIREMENTS FOR ALL METHODS 7.1 Minimum General Requirements The requirements in this section and Section 3 apply to laboratory analysis for all methods, including requirements for QA, QC checks, training, chain of custody, data validation , reporting, quality systems , approved devices and qualified laboratories, measurement system calibration and default minimum control limits. All of the requirements in this section and in Section 3 apply to charcoal adsorption devices (analyzed with gamma counting or liquid scintillation analysis) and alpha track devices. Responses for both devices depend on the material used in the detectors as well as the particular device model configuration; calibrations and QC checks are to be specific to both materials and configurations. 7.2 Laboratory Specific QA Laboratories shall be responsible for developing, documenting and implementing procedures for defensible QC processes and assessments that include a full calibration conducted specifically for each laboratory, device configuration/material and analysis system configuration, and for monitoring data imprecision and bias that results from the quality system measurement process, including shipping. QC records are to be maintained and retained so that QC processes can be reviewed for internal improvement and are available to auditors and credentialing authorities, subject to confidentiality agreements. The requirements herein are minimum requirements for procedures to be included in a Quality Assurance Plan with QC checks logged in QC records. Most analysis laboratories will have additional QC procedures to meet their quality system’s requirements. 7.3 Responsibilities Ensuring adequate QC within the laboratory is the responsibility of laboratory management, with duties often assigned to quality managers. Adequate QA includes verification and documentation of: a) sufficient training of individuals responsible for laboratory operations; b) verifying that the detection media quality as well as the materials used (charcoal or alpha-sensitive plastic, scintillant, etc.) meet the QAP requirements; c) continued applicability of the calibration factors and functions (curves); d) QC operations conducted at required frequencies, with results within warning and control limits or appropriate investigative and corrective actions taken, as needed; e) maintenance of equipment and system; and f) quality policies as specified in a QAP, revised as operations change, and records of all QC checks, which are available to auditors or credentialing authorities, subject to confidentiality agreements. 7.4 Lab QC of Detector Materials Detector response is dependent on the batch -specific properties of activated charcoal or alpha-sensitive plastic, which is used when assembling the detector. It is the responsibility of the laboratory to: a) ensure the detector material background properties and response to radon concentrations (sensitivity) are known and consistent within the limits set by the laboratory; b) track which detectors are made from specific materials so that the correct calibration functions (curves) are applied as well as aid in investigations of imprecision, failed spikes , blanks or other QC results, such as successions of blanks greater than the MDC; and c) determine shelf life beyond which the laboratory can no longer warrant the detector to be reliable.