NR 149.37(1)(1)
Purpose and general provisions. Each laboratory shall define its quality system in a quality manual. All policies and procedures governing the laboratory's quality system shall be documented or referenced in the quality manual. All laboratory personnel shall follow the policies and procedures established by the quality manual.
NR 149.37(2)
(2)
Format. The quality manual shall have a format that addresses the content elements specified in this section. Content elements may be presented in narrative, tabular, schematic, or graphical form. The manual shall be a document in hard copy or electronic format traceable to the laboratory.
NR 149.37(3)
(3)
Content. Unless included in other standard operating procedures maintained under s.
NR 149.40, the quality manual shall include, address, or refer to all the following elements:
NR 149.37(3)(a)
(a) Procedures for retention, control, and maintenance of documents used in or associated with analysis.
NR 149.37(3)(b)
(b) Procedures for achieving traceability of standards, reagents, and reference materials used to derive any results or measurements.
NR 149.37(3)(d)
(d) Procedures for calibration, verification, and maintenance of support equipment.
NR 149.37(3)(f)
(f) Procedures for initiating, following up on, and documenting corrective action, addressing quality assurance and quality control failures, and any discrepancies or nonconformances.
NR 149.37(4)
(4)
Revisions. The quality manual shall be kept current. All editions or versions of the quality manual shall indicate the dates in which the quality manual was issued or revised.
NR 149.37 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.38(1)(1)
The laboratory shall take corrective action in response to any nonconformances including all the following:
NR 149.38(1)(a)
(a) Departures from established procedures in the quality system are identified.
NR 149.38(1)(b)
(b) Quality control samples fail, unless immediate reanalysis of the affected sample resolves the issue.
NR 149.38(2)
(2) The corrective action under sub.
(1) shall identify the problem, determine the most probable cause of the problem, implement solutions to correct the problem, and include a mechanism to verify that the action has had the desired effect.
NR 149.38(3)
(3) The laboratory shall document corrective action taken to address the nonconformance under sub.
(1) and any other changes resulting from corrective action investigations. Changes implemented to address failures of quality control samples shall be those that resolve or address the failure. Changes shall be implemented to minimize the number of affected results reported by a laboratory.
NR 149.38(4)
(4) The laboratory shall monitor the effectiveness of implemented corrective action changes and take additional corrective action when initial or subsequent corrective action fails to resolve the nonconformance.
NR 149.38 Note
Note:
The analyst may not always be able to identify the cause of isolated nonconformance incidents.
NR 149.38(5)
(5) Root cause analysis shall be performed when there is recurrence.
NR 149.38 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.39(1)(1)
Records and documents retention and control. NR 149.39(1)(a)
(a) The laboratory shall establish procedures to control and manage all records and documents that form part of its quality system and that are required to demonstrate compliance with this chapter.
NR 149.39(1)(b)
(b) The procedures shall ensure that documents required to perform analyses and to ensure the quality of generated data are available to laboratory personnel, and that records and documents are reviewed periodically for continuing suitability and, when necessary, revised to facilitate compliance with the requirements of this chapter.
NR 149.39(1)(c)
(c) The laboratory shall retain all records and documents, which are part of its quality system, and that are required to demonstrate compliance with this chapter, for a minimum of three years after the generation of the last entry in an associated record or document. The laboratory shall retain records and documents for a longer minimum period if the records and documents are necessary to reconstruct analytical results generated during a three-year period.
NR 149.39(1)(d)
(d) The department may require, in writing, that records be retained for a longer period than that specified in par.
(c) if the department has initiated legal action involving test results or the accreditation status of the laboratory.
NR 149.39(1)(e)
(e) The laboratory shall identify to the department a responsible party for retaining documents and records for the required period in the event the laboratory changes ownership or ceases to be accredited.
NR 149.39(1)(f)
(f) Records and documents shall be handled and stored in a manner that ensures permanence and security for the required retention period and that facilitates retrieval to demonstrate compliance with this chapter.
NR 149.39(1)(g)
(g) All records shall allow for reconstruction of reported results from raw data. Records and documents shall be legible, and entries shall be safeguarded against obliteration, erasures, overwriting, and corruption and are subject to all the following requirements:
NR 149.39 Note
Note:
The determination of legibility includes concerns regarding the quality and permanence of records and the ability to decipher numbers and letters. For example, thermal paper ages and eventually becomes unreadable, so thermal paper printouts should ultimately be scanned or copied to ensure permanence.
NR 149.39(1)(g)2.
2. Records and documents that are stored only on electronic media shall be supported by the hardware and software necessary for retrieval and reproduction into hard copy.
NR 149.39(1)(g)3.
3. Corrections or other alterations made to entries in records or documents may not obscure the original entry.
NR 149.39(1)(g)4.
4. The laboratory shall have procedures to prevent unauthorized access or amendments to records and documents.
NR 149.39(2)
(2)
Administrative records. A laboratory shall maintain all the following administrative records:
NR 149.39(2)(a)
(a) Certificates of accreditation issued by the department unless the department has requested a laboratory to return the certificates to the department.
NR 149.39(2)(b)
(b) Certificates issued to the laboratory by entities with which the department has entered into a reciprocal agreement under s.
NR 149.08, if a laboratory is accredited for this chapter under any existing agreement.
NR 149.39(2)(c)
(c) Records of personnel qualifications, experience, and training when personnel are required to possess or maintain specific credentials by s.
NR 149.36 (2).
NR 149.39(2)(d)
(d) Copies of, or access to, other regulations, standards, and documents necessary for the laboratory to operate or to maintain compliance with this chapter.
NR 149.39(3)
(3)
Reagent and standard records and reference materials. The laboratory shall document the identity, source, and purity of standards and reagents used in the methods performed. The laboratory shall retain records of reference materials and certificates of analysis when the records are provided by the supplier and are necessary to establish the identity, source, or purity of standards and reagents.
NR 149.39(3)(a)
(a) Reagent containers shall be labeled with an expiration date, chemical name, and concentration. Except for instrument vials, standard containers shall be labeled with an expiration date, chemical name, and concentration.
NR 149.39(3)(b)
(b) The laboratory shall document the lot number, manufacturer, chemical name, concentration, and the date of expiration for standards and reagents purchased from a manufacturer. These records shall be separate from the container labels.
NR 149.39 Note
Note:
An expiration date is not required when one is not provided by the supplier.
NR 149.39(3)(c)
(c) The laboratory shall document the preparation details of all prepared standards and reagents. These records shall link the prepared standards and reagents to the respective originating stocks or neat compounds and shall indicate the date of preparation, date of expiration, and the identity of the preparer.
NR 149.39(3)(d)
(d) The laboratory may not use any standards and reagents beyond the expiration dates unless the laboratory is using the standard and reagents for qualitative determinations.
NR 149.39(3)(e)
(e) Certificates for all reference materials shall be maintained.
NR 149.39(4)
(4)
Analytical and technical records. The format of the analytical and technical records of a laboratory shall facilitate access to the information in this subsection and may be contained in bench sheets, log books, notebooks, journals, manuals, standard operating procedures under s.
NR 149.40, and forms, in hard copy or electronic media.
NR 149.39(5)
(5)
Sample collection records. The laboratory shall retain records supplied by the collector to allow the laboratory to evaluate collection information against the laboratory's sample acceptance policy.
NR 149.39 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.40
NR 149.40
Standard operating procedures. NR 149.40(1)(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.
NR 149.40 Note
Note:
Sample preparation includes digestions, distillations, extractions, concentrations, dilutions, and clean-up performed on samples prior to the determinative analytical step.
NR 149.40(2)
(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.
NR 149.40(3)
(3) Standard operating procedures may consist, in part, of copies of published documents, manuals, or procedures if all the following conditions are met:
NR 149.40(3)(a)
(a) Modifications to the published source are described in writing in additional documents.
NR 149.40(3)(b)
(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.
NR 149.40(4)
(4) Standard operating procedures shall indicate the dates of issue or revision.
NR 149.40(5)
(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:
NR 149.40(5)(c)
(c) Potential interferences and how the interferences are treated.
NR 149.40(5)(j)
(j) Data assessment and acceptance criteria for quality control measures.
NR 149.40(5)(k)
(k) Corrective actions and contingencies for handling out of control or unacceptable data.
NR 149.40 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.41(1)(1)
The laboratory shall use methods for environmental testing required by covered programs under this chapter and that are suitable for the matrix, type of analyte, expected level of analyte, regulatory limit, and potential interferences in the samples to be tested.
NR 149.41 Note
Note:
Sources, including the following as updated, likely contain methods that are acceptable for testing under this chapter: The EPA, the department, Standard Methods for the Examination of Water and Wastewater, Test Methods for Evaluating Solid Waste, Physical/Chemical Methods – SW-846, American Society for Testing and Materials, and the U.S. Geological Survey Agency.
NR 149.41(2)
(2) When methods are not specified by covered programs under this chapter or specified in permits issued by the department, the laboratory shall consult with the department to select a method that meets the requirements in sub.
(1).
NR 149.41(3)
(3) When using methods associated with the methods compendium document, “Test Methods for Evaluating Solid Waste,” the laboratory shall comply with the minimum requirements of the methods as written and state which options are being implemented when options exist.
NR 149.41 Note
Note:
The documents above can be found on the Wisconsin department of natural resources laboratory accreditation program website and are available for inspection at the offices of the department and the legislative reference bureau.
NR 149.41(4)
(4) The department will assess the scientific validity of method modifications to determine if the modification is within the scope of a method.
NR 149.41 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.42(1)(1)
The department may allow the use of alternative methods from those required by covered programs, including the safe drinking water program, if a laboratory requests approval and if the EPA has granted approval for the alternative methods.
NR 149.42(2)
(2) On a case-by-case basis, the department may allow the use of methods other than those required by covered programs for any of the following situations:
NR 149.42(2)(a)
(a) After consultation with the department, the manager of a covered program determines that the allowance does not result in a detrimental effect on the quality and defensibility of the results to be generated.
NR 149.42(2)(b)
(b) The request is for approval of a method that employs a new or emerging technology and there is documentation that substantiates the validity of the new or emerging technology for the intended purpose.
NR 149.42(3)
(3) Requests to use an alternative method shall include the reason for seeking the approval, a description of the principles of any new or emerging technology involved, and the potential scope of application of the method. The department may establish criteria for validating the method for the specific application and scope requested. If the laboratory's method validation results meet the established validation criteria, the department shall allow the use of the method for the specific application and scope requested.
NR 149.42(4)
(4) The department shall approve or deny the request for consideration of approval for use within 90 days from the receipt of the request. The department shall consider in its decision whether the covered programs that would be the recipients of the data generated have a demonstrated need for allowing the alternative method.
NR 149.42(5)
(5) The department may charge a fee under s.
299.11 (5) (d), Stats., if it is necessary to verify the results of any validation data submitted by a laboratory requesting use of an alternative method.
NR 149.42 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21.
