Section 149.45. Measurement traceability.

 

(1)   Standards, reagents and reference materials .

(a) The laboratory shall ensure that results of analyses can be linked to all the standards and reagents used to derive results. Standards and reagents used in analyses shall conform to the purity specifications contained in approved methods of analysis. When approved methods of analysis do not specify the purity of the standards and reagents to be used, the laboratory shall choose standards and reagents of sufficient purity to ensure the validity of reported results.

(b) The laboratory shall certify the accuracy of all reference materials used to calibrate or verify the calibration of analytical support equipment. Reference materials shall be calibrated by a body independent of that in charge of analytical operations that can provide traceability to primary standards maintained by NIST. When reference materials traceable to NIST are not produced, manufactured or commercially available, the laboratory shall use materials of a quality that will ensure the accuracy of the calibrated or verified support equipment for its intended use.

(c) The laboratory may not use standards and reagents beyond their expiration dates, unless the laboratory can verify their reliability in a defensible manner.

(2)   Documentation and labeling of standards, reagents and reference materials.

(a) The laboratory shall document the identity, source and purity of all standards and reagents used in tests methods performed. The laboratory shall retain records of certificates of analysis or purity, when the records are provided by the supplier, and are necessary to establish the identity, source or purity of standards and reagents.

1. Original containers of standards and reagents shall be labeled with a receipt and an expiration date.

2. The laboratory shall document the lot number, manufacturer, date of receipt and the date of expiration of stock standards and reagents separately from their containers to ensure this information will be retained when the containers are discarded.

3. The laboratory shall maintain records that detail the preparation of intermediate and working standards and reagents. These records shall link the intermediate and working standards and reagents to their respective originating stocks or neat compounds and shall indicate their date of preparation, expiration and the identity of the preparer.

(b) The laboratory shall retain records and certificates that trace reference materials used to calibrate or verify analytical support equipment to the source of the corresponding reference materials. The laboratory shall retain records demonstrating that the accuracy of the reference materials has been certified or verified, at the required frequencies, by a body outside of that in charge of analytical operations.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.