Current through August 26, 2024
(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.
