Section NR 149.40 - Standard operating procedures(1) A laboratory shall maintain written standard operating procedures that document or reference activities needed to maintain its quality systems and that enable performing or reproducing an analysis in its entirety as performed at the laboratory. Each laboratory shall develop, maintain, and keep current its standard operating procedures for both sample preparation and analysis. Note: Sample preparation includes digestions, distillations, extractions, concentrations, dilutions, and clean-up performed on samples prior to the determinative analytical step.
(2) Standard operating procedures may be documents written by laboratory personnel or may consist entirely of copies of published documents, manuals, or procedures if the laboratory follows the chosen source exactly.(3) Standard operating procedures may consist, in part, of copies of published documents, manuals, or procedures if all the following conditions are met: (a) Modifications to the published source are described in writing in additional documents.(b) Clarifications, changes, or choices are completely described in additional documents, when published sources offer multiple options, ambiguous directives, or insufficient detail to perform or reproduce an analysis.(4) Standard operating procedures shall indicate the dates of issue or revision.(5) When the standard operating procedure is written by the laboratory, each standard operating procedure shall include, address, or refer to all the following elements, if applicable: (a) Identification of the referenced method.(b) For multi-analyte methods, a list of analytes.(c) Potential interferences and how the interferences are treated.(d) Equipment and analytical instruments.(e) Consumable supplies, reagents, and standards.(f) Sample preservation, storage, and hold time.(g) Quality control samples and frequency of the analysis. (h) Calibration and standardization.(i) Procedure for analysis.(j) Data assessment and acceptance criteria for quality control measures.(k) Corrective actions and contingencies for handling out of control or unacceptable data.Wis. Admin. Code Department of Natural Resources NR 149.40
CR 06-005: cr. Register April 2008 No. 628, eff. 9-1-08.Amended by, CR 17-046: cr. Register February 2021 No. 782, eff. 6/29/2021