Section 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 that are part of its quality system and that are required to demonstrate compliance with this chapter for a minimum of 3 years after the generation of the last entry in a record or document. The laboratory shall retain records and documents for a longer minimum period, if they are necessary to reconstruct analytical results generated during a 3-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 certification or registration 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 certified or registered.

(f) Records and documents shall be handled and stored in a manner that ensures their permanence and security for the required retention period, and that facilitates their retrieval to demonstrate compliance with this chapter.

(g) Records and documents shall be legible and their entries shall be safeguarded against obliteration, erasures, overwriting and corruption.

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 their 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. Administrative records that laboratories shall maintain include:

(a) Certificates of certification or registration issued by the department, unless the department has requested a laboratory to return them.

(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 certified or registered 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) Records of demonstration of capability for each analyst required to perform the demonstrations specified in s. NR 149.36 (3) .

(e) Copies of or access to other regulations, standards and documents necessary for the laboratory to operate or to maintain compliance with this chapter.

(3)   Analytical and technical records.

(a) The laboratory shall maintain all analytical and technical records containing raw and derived data, or original observations, necessary to allow historical reconstruction of all laboratory activities that contributed to generating reported results.

(b) 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 and forms, in hard copy or electronic media.

(c) Analytical and technical records retained by the laboratory shall allow access to information that includes:

1. Collection, arrival, processing and analysis dates of samples received for analysis.

2. Collection and analysis time for tests with holding time of 48 hours or less.

3. Preservation status of samples on arrival at the laboratory.

4. Identity of laboratory personnel preparing and testing samples.

5. Identification of the analytes or analyte groups analyzed in samples.

6. Preparatory techniques, such as digestions, extractions and clean-ups, to which samples are submitted.

7. Methods of analysis used for samples.

8. Results of sample analysis.

9. Traceability of standards and reagents used to perform analysis.

10. Calibration verification information and measurements of laboratory support equipment associated with sample analysis and storage.

11. Initial and continuing calibration data associated with samples analyzed.

12. Raw data for analytical instrument calibrations and samples. The department has exempted the retention of emission counts for samples and standards analyzed after an initial calibration for older models of inductively coupled plasma emission spectrophotometers that are incapable of providing that information when operated in the instrument calibration mode.

13. Results of quality control samples associated with samples analyzed.

14. Corrective actions associated with samples analyzed.

15. Maintenance performed on laboratory support equipment and analytical instruments.

16. Environmental conditions crucial to tests performed at laboratory facilities at the time samples are analyzed.

17. Reports of final results submitted to clients or the department.

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