Okla. Admin. Code § 35:25-3-7

Current through Vol. 42, No. 4, November 1, 2024

Section 35:25-3-7 - Calibration system requirements

(a)Calibration policies. Applicants will make available to the State Department of Agriculture written policies for his calibration system. The policies dealing with measuring and test equipment shall prescribe calibration intervals and sources and define his inspection operations.

(b)Adequacy of standards. Standards established by the laboratory for calibrating the measuring and test equipment used in controlling product quality shall have the capabilities for accuracy, stability, and range required for the intended use.

(c)Environmental controls. Measuring and test equipment and measurement standards shall be calibrated and utilized in an environment controlled to the extent necessary to assure continued measurements of required accuracy giving due consideration to temperature, humidity, vibration, cleanliness, and other controllable factors affecting precision measurement. When applicable, compensating corrections shall be applied to calibration results obtained in an environment which departs from standard conditions.

(d)Intervals of calibration. Measuring and test equipment and measurement standards shall be calibrated at established periodic intervals on the basis of stability, purpose, and degree of usage. Intervals shall be shortened as required to assure continued accuracy as evidenced by the results of preceding calibrations and may be lengthened only when the results of previous calibrations provide definite indications that such action will not adversely affect the accuracy of the system.

(e)Calibration procedures. Written procedures shall be prepared or provided and utilized for calibration of all measuring and test equipment and measurement standards used to assure the accuracy of measurements involved in establishing product conformance. The procedures may be a compilation of published standard practices or manufacturer's written instructions and need not be rewritten to satisfy the requirements of this regulation. The procedures shall require that calibration be performed by comparison with higher accuracy level standards. A description of calibration standards shall be included in the procedures and shall consist essentially of a listing of the applicable measurement standards, both reference and transfer, and shall provide nomenclature, identification number, calibration interval and source, and environmental conditions under which the measurement standards will be applied and calibrated.

(f)Calibration source. Measuring and test equipment shall be calibrated by the laboratory or a commercial facility utilizing reference standards (or transfer standards) whose calibration is certified as being traceable to the National Bureau of Standards, has been derived from accepted values of natural physical constants, or has been derived by the ratio type of self-calibration techniques. Reference standards requiring calibration by a higher level standards laboratory shall be calibrated by a commercial facility capable of providing the required service, a government laboratory, or by the National Bureau of Standards. All reference standards used in the calibration system shall be supported by certificates, reports, or data sheets attesting to the date, accuracy, and conditions under which the results furnished were obtained. All subordinate standards and measuring and test equipment shall be supported by like data when such information is essential to achieving the accuracy control required by this specification. In those cases where no data is required, a suitably annotated calibration label on the item shall be sufficient to satisfy the support data requirements of this subsection. Certificates or reports from other than the National Bureau of Standards or government laboratory shall attest to the fact that the standards used in obtaining the results have been compared at planned intervals with the National Standard either directly or through a controlled system utilizing the methods outlined above. The laboratory shall be responsible for assuring that the sources providing calibration services, other than the National Bureau of Standards or a government laboratory, are in fact capable of performing the required service to the satisfaction of this specification. All certificates and reports shall be available for inspection.

(g)Foreign contracts. The provisions in subsection (e) shall apply with the exception that the National Standards Laboratories of countries whose standards are compared with International or U.S. National Standards may be utilized in lieu of the U. S. National Bureau of Standards.

(h)Maintenance of records. The application of the requirements in (a) through (g) of this section will be supported by records designed to assure that established schedules and procedures are followed to maintain the accuracy of all measuring and test equipment, and supporting standards. The records shall include a suitably identified individual record of calibration or other means of control for each item of measuring and test equipment and measurement standards, providing calibration interval and date of certification of results of last calibration. In addition, the individual record of any item whose accuracy must be reported via a calibration report or certificate will quote the report or certificate number for ready reference. Records of equipment and its disposal shall be maintained for a period of three (3) years. These records shall be available for review by authorized State Department of Agriculture personnel.

(i)Calibration labeling. Measuring and test equipment and measurement standards shall be labelled to indicate the date of last calibration, by whom it was calibrated, and when the next calibration is due. When the size or functional characteristics limit the application of label, an identifying code shall be applied to the item to reflect serviceability and due date for next calibration. When neither labelling or coding is practical, the system shall provide suitable procedures for monitoring of recall records to assure adherence to calibration schedules. Label, codes, or recall records for items which are not required to be used to their full capabilities, or items which require functional check only shall indicate the applicable condition.

Okla. Admin. Code § 35:25-3-7