Section NR 149.39 - Records and documents(1) RECORDS AND DOCUMENTS RETENTION AND CONTROL. (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.(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. (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.(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.(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.(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.(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: 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.
1. Handwritten records shall be recorded in ink.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.3. Corrections or other alterations made to entries in records or documents may not obscure the original entry.4. The laboratory shall have procedures to prevent unauthorized access or amendments to records and documents.(2) ADMINISTRATIVE RECORDS. A laboratory shall maintain all the following administrative records: (a) Certificates of accreditation issued by the department unless the department has requested a laboratory to return the certificates to the department.(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.(c) Records of personnel qualifications, experience, and training when personnel are required to possess or maintain specific credentials by s. NR 149.36(2).(d) Copies of, or access to, other regulations, standards, and documents necessary for the laboratory to operate or to maintain compliance with this chapter.(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. (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.(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. Note: An expiration date is not required when one is not provided by the supplier.
(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.(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.(e) Certificates for all reference materials shall be maintained.(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.(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.Wis. Admin. Code Department of Natural Resources NR 149.39
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