NR 149.30(1)(1)
The department shall perform on-site evaluations of laboratories to evaluate systems, practices, procedures, and documentation in a laboratory and to identify deficiencies according to documented procedures that promote consistency in determining a laboratory's potential, actual, or continued ability to comply with this chapter.
NR 149.30(2)
(2) If, in performing an on-site evaluation, the department finds that the laboratory is implementing a procedure that is neither allowed nor disallowed by method or this chapter, the department will assess the scientific validity of the procedure. The department may seek the advice of the council in making determinations under this subsection.
NR 149.30(3)
(3) The department shall provide laboratories with a survey to allow them to appraise the evaluation process.
NR 149.30 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21; correction in (2) made under s. 13.92 (4) (b) 7., Stats., Register February 2021 No. 782. NR 149.31(1)(1)
The department shall document the deficiencies identified during an on-site evaluation under s.
NR 149.30 in reports issued to the evaluated laboratory.
NR 149.31(2)
(2) The report of an on-site evaluation shall be issued to a laboratory within 30 days of the conclusion of the on-site visit. When the department finds it necessary to issue an evaluation report at a date later than 30 days after the conclusion of an on-site visit, the department shall notify the laboratory about the delay. The notice shall include an expected delivery date for the report.
NR 149.31 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.32
NR 149.32
Evaluation corrective action. NR 149.32(1)(1)
A laboratory shall take corrective action to address all deficiencies discovered during an on-site evaluation under s.
NR 149.30 and contained in an evaluation report under s.
NR 149.31.
NR 149.32(2)
(2) A laboratory shall submit to the department, within 30 days from the evaluation report's date, a plan of corrective action to address all the deficiencies noted in the report. When a laboratory finds it necessary to submit a corrective action plan at a date later than 30 days after the evaluation report's date, the laboratory shall notify the department about the delay and provide an expected delivery date in consultation with the department.
NR 149.32(3)
(3) The department shall review the corrective action plan submitted by a laboratory under sub.
(2) and inform the laboratory whether the submitted plan addresses satisfactorily all noted deficiencies, or whether additional action or documentation is necessary to determine the laboratory's ability to comply with this chapter, subject to all the following:
NR 149.32(3)(a)
(a) When the department determines that the submitted corrective action plan addresses all noted deficiencies satisfactorily, the department shall inform the laboratory in writing within 30 days that the plan is acceptable.
NR 149.32(3)(b)
(b) When the department determines that additional action or documentation is needed to evaluate compliance with this chapter, the department, in consultation with the laboratory, shall set a date for the laboratory to submit a second corrective action plan.
NR 149.32(3)(b)1.
1. If the department determines that the second corrective action plan submitted under sub.
(3) (b) addresses all noted deficiencies satisfactorily, the department shall inform the laboratory in writing that the evaluation process has concluded.
NR 149.32(3)(b)2.
2. If the department determines that the second corrective action plan submitted under sub.
(3) (b) does not address all the noted deficiencies satisfactorily, the department may schedule another on-site evaluation to determine the laboratory's compliance with this chapter, terminate any outstanding application that led to the original on-site evaluation, or direct enforcement to the laboratory.
NR 149.32(3)(b)3.
3. If a second on-site evaluation is scheduled as a follow-up to a second corrective action plan submitted under sub.
(3) (b), the department shall establish deadlines that resolve any remaining unresolved deficiencies expeditiously, but no later than 90 days after the conclusion of the follow-up visit.
NR 149.32 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.33(1)(1)
The department shall establish procedures to ensure and document that laboratory evaluators under its employment are free of any conflicts that would render the laboratory evaluator incapable of performing an objective and unbiased evaluation of a laboratory.
NR 149.33(2)
(2) A laboratory may request information and documents used by the department to establish that any evaluator assigned to perform the laboratory's evaluation is free of any conflicts of interest.
NR 149.33 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.34
NR 149.34
Evaluator qualifications. NR 149.34(1)(1)
The department shall develop procedures to establish and evaluate the education, experience, and credentials of the laboratory evaluators under its employment.
NR 149.34(2)
(2) A laboratory may request information and documents used by the department to establish that any evaluator assigned to perform the laboratory's evaluation has the necessary education, experience, or credentials to perform evaluations competently.
NR 149.34 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.35(1)(1)
Scope. This subchapter establishes personnel, quality assurance, quality control, method selection, sample handling, and documentation requirements for laboratories.
NR 149.35(2)
(2)
Responsibility for quality system. A laboratory shall conduct analytical activities under a quality system that incorporates the provisions of this subchapter. At least one individual within a laboratory's organization or under the laboratory's employment shall be identified to the department as responsible for establishing, implementing, assessing, and revising, as needed, a laboratory's quality system.
NR 149.35 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.36(1)(1)
Management and analytical staff. The laboratory shall have personnel with education, training, or experience that allows the laboratory to comply with the requirements of this chapter. Contractors, external to the laboratory, may serve in key laboratory roles. When external contractors serve in essential laboratory roles, the contracts shall be available to the department to ensure that contractual specifications satisfy the requirements of this chapter.
NR 149.36 Note
Note:
For requirements regarding changes in key personnel see s.
NR 149.155.
NR 149.36(2)(a)
(a) When a laboratory references a method that contains procedures for demonstrating initial capability, continuing capability or both, personnel performing analyses using these methods shall perform the procedures, meet any associated evaluation criteria, and document the results. When initial demonstrations of capability include the analysis of samples, the samples shall be prepared from a clean matrix and processed through all method preparation steps.
NR 149.36(2)(b)
(b) When a laboratory references a method that does not contain procedures for demonstrating initial capability, the laboratory shall establish initial demonstration of capability criteria for determining that each person who performs testing on compliance samples using the method has demonstrated the necessary skills and expertise required to generate quality analytical results. The laboratory shall retain documentation that each person performing a given test on compliance samples has satisfied the demonstration of capability criteria established by the laboratory.
NR 149.36 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.365
NR 149.365
Laboratory ethics. All the following practices are prohibited and may result in enforcement action under s.
NR 149.10:
NR 149.365(1)
(1) Fabrication, falsification, or misrepresentation of data.
NR 149.365(2)
(2) Improper instrument clock setting, termed time traveling, or improper recording of date or time.
NR 149.365(3)
(3) Unwarranted manipulation of samples, software, peak integration, or analytical conditions.
NR 149.365(4)
(4) Concealing or failing to report a known improper or unethical behavior or action associated with sample analysis.
NR 149.365 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. 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.
