Ariz. Admin. Code § R9-14-615 - Quality Assurance
A. A
licensee or applicant shall ensure that the analytical data produced at the
licensee's or applicant's laboratory are of known and acceptable precision and
accuracy, as prescribed by the approved method for each analysis or as
prescribed by the limits described under subsection (C)(8), and are
scientifically valid and defensible.
B. A licensee or applicant shall establish,
implement, and comply with a written quality assurance plan that contains the
following and is available at the laboratory for Department review:
1. A title page identifying the laboratory
and date of review and including the laboratory director's signature of
approval;
2. A table of
contents;
3. An organization chart
or list of the laboratory personnel, including names, lines of authority, and
identification of principal quality assurance personnel;
4. A copy of the current laboratory license
and a list of licensed parameters;
5. A statement of quality assurance
objectives, including data quality objectives with precision and accuracy goals
and the criteria for determining the acceptability of each testing;
6. Specifications for:
a Sample containers,
b. Preparation of sample
containers,
c. Preservation of
samples, and
d. Maximum holding
times allowed;
7. A
procedure for documenting laboratory receipt of samples and tracking of samples
during laboratory testing;
8. A
procedure for analytical instrument calibration, including frequency of
calibration and complying with the requirements for calibration in subsection
(C);
9. A procedure for compliance
testing data reduction and validation and reporting of final results, including
the identification and treatment of data outliers, the determination of the
accuracy of data transcription, and all calculations;
10. A statement of the frequency of all
quality control checks;
11. A
statement of the acceptance criteria for all quality control checks;
12. Preventive maintenance procedures and
schedules;
13. Assessment
procedures for data acceptability, including appropriate procedures for manual
integration of chromato-grams and when manual integration is
inappropriate;
14. Corrective
action procedures to be taken when results from analytical quality control
checks are unacceptable, including steps to demonstrate the presence of any
interference if the precision, accuracy, or limit of quantitation of the
reported compliance testing result is affected by the interference;
and
15. Procedures for
chain-of-custody documentation, including procedures for the documentation and
reporting of any deviation from the sample handling or preservation
requirements listed in this Section.
C. A licensee or applicant shall:
10.
9. Discard or
segregate all expired standards or reagents;
11.
10. Maintain a record
showing the traceability of reagents; and
12.
11. Ensure that a
calibration model is not used or changed to avoid necessary instrument
maintenance.
1. Have available ant the laboratory all
methods, equipment, reagents, and glassware necessary for the compliance
testing for which the licensee or applicant is licensed or is requesting a
license;
2. Use only reagents of a
grade equal to or greater than that required by the approved methods and
document the use of the reagents;
3. Maintain and require each analyst to
comply with a complete and current standard operating procedure that meets the
requirements for each licensed method which shall include at least:
b.
a. A
description of all procedures to be
c.
b. A list of the
concentrations for calibration standards, check standards, and spikes;
d.
c. Requirements for instrumental conditions and set
up;
e.
d. A requirement for frequency of
calibration;
f
e. The quantitative methods to be used to calculate
the final concentration of an analyte in samples, including any factors used in
the calculations and the calibration algorithm used, and
f. Requirements for preventative
maintenance;
4.
Calibrate each instrument as required by each approved method for which the
equipment is used, as follows:
a. If a
calibration model is specified in the method, using the specified calibration
model or, if another calibration model has been approved by the Department as a
method alteration, using the calibration model approved as a method
alteration;
b. If multiple
calibration models are included as options in the method, using one of the
included calibration models or, if another calibration model has been approved
by the Department as a method alteration, using the calibration model approved
as a method alteration; or
c. If
the method does not include a calibration model, using the manufacturer's
specifications for calibration;
5. Maintain calibration documentation,
including documentation that demonstrates the calculations performed using each
calibration model;
6. Develop,
document, and maintain a current limit of detection and limit of quantitation
for each compliance parameter for each instrument;
7. Develop each limit of detection using:
a. The protocol in the applicable test
method;
b. The protocol in the
applicable federal regulation; or
c. A process that complies with the
guidelines in Section D.1.2 of Chapter 5, Appendix D-Essential Quality Control
Requirements, in Key Reference H;
8. For each parameter tested at the
laboratory for which quality control acceptance criteria are not specified in
the approved method or by EPA or ADEQ:
a. Use
default limits provided in Table 6.4; or
b. Statistically develop limits from
historical data by:
i. Determining the mean
and standard deviation for a minimum of 20 data points not invalidated for
cause, excluding statistical outliers;
ii. Setting the limits no more than three
standard deviations from the mean and in the detectable range, using as the
lower end of the detectable range the limit of quantitation or the lowest
standard value represented in the initial calibration; and
iii. Explaining the origin of the lower end
of the detectable range in the laboratory's standard operating procedure;
D. A
licensee or applicant may submit a written request to the Department for an
exemption from subsection (C)(1) for a specific parameter if the licensee or
applicant documents:
1. That the approved
method has been performed at the laboratory and that the analytical data
generated were scientifically valid and defensible and of known and acceptable
precision and accuracy; and
2. The
licensee's or applicant's ability to obtain the equipment, reagent, or
glassware necessary to perform the approved method.
E. The written request for an exemption under
subsection (D) shall include:
1. The name,
address, and main telephone number of the laboratory;
2. The name, address, and telephone number of
the licensee or applicant submitting the request;
3. Identification of the parameter and the
equipment, reagent, or glassware for which the licensee or applicant is
requesting an exemption; and
4. The
documentation described in subsections (D)(1) and (2).
F. The Department may approve a request for
an exemption under subsection (D) if the Department determines that the:
1. Approved method has been performed at the
laboratory;
2. Analytical data
generated were scientifically valid and defensible and of known and acceptable
precision and accuracy; and
3.
Licensee or applicant is able to obtain the equipment, reagent, or glassware
necessary to perform the approved method.
G. A licensee or applicant shall ensure that
a laboratory's written quality assurance plan is a separate document available
at the laboratory and includes all of the components required in subsection
(B), but a licensee or applicant may satisfy the components required in
subsections (B)(3) through (15) through incorporating by reference provisions
in separate documents, such as standard operating procedures.
H.
A
Except as provided in subsection (I), a licensee or applicant shall ensure that
each laboratory standard operating procedure is a separate document available
at the laboratory and includes all of the components required in subsection
(C)(3).
I. A licensee or applicant
may satisfy the components required in subsections (C)(3)(e) and (f) through
incorporating by reference provisions in separate documents, such as other
standard operating procedures.
Notes
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