Section 149.40. Standard operating procedures.

 

(1)   General requirements.

(a) Laboratories shall maintain written standard operating procedures that document or reference activities needed to maintain their quality systems and that enable performing or reproducing an analysis in its entirety as performed at the laboratory.

(b) 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.

(c) Standard operating procedures may consist in part of copies of published documents, manuals or procedures if:

1. Modifications to the published source are described in writing in additional documents.

2. 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.

(d) Standard operating procedures shall indicate their dates of issue or revision.

(2)   Analytical methods manual.

(a) The laboratory shall have and maintain a list describing analytical test methods performed for programs covered by this chapter.

(b) The analytical methods manual may consist of published or referenced test methods, or standard operating procedures written by the laboratory as allowed in this section.

(c) The essential elements of test methods required in par. (d) may be presented in narrative, tabular, schematic or graphical form. The analytical methods manual shall be an identifiable document in hard copy or electronic format traceable to the laboratory.

(d) When the analytical methods manual consists of standard operating procedures written by the laboratory, each standard operating procedure shall include, address or refer to, at a minimum, the following elements:

1. Identification of the test method.

2. Applicable analytes.

3. Applicable matrices.

4. Method sensitivity.

5. Potential interferences.

6. Equipment and analytical instruments.

7. Consumable supplies, reagents and standards.

8. Sample preservation, storage and hold time.

9. Quality control samples and frequency of their analysis.

10. Calibration and standardization.

11. Procedure for analysis.

12. Data assessment and acceptance criteria for quality control measures.

13. Corrective actions and contingencies for handling out of control or unacceptable data.

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