EXAMPLE OF A TECHNICAL

SYSTEMS AUDIT CHECKLIST

FOR A LABORATORY MEASUREMENT SYSTEM

Audited Project:
Auditee:
Audit Location:
Auditors:
Audit Dates:
Brief Project Description:

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A. QUALITY SYSTEM DOCUMENTATION

1. Is there an approved QA Project
Plan for the overall project and has
it been reviewed by all appropriate
personnel?
2. Is a copy of the current approved
QA Project Plan maintained at the
site? If not, briefly describe how
and where quality assurance (QA)
and quality control (QC)
requirements and procedures are
documented at the site.
3. Is the implementation of the project
in accordance with the QA Project
Plan?
4. Are there deviations from the QA
Project Plan? Explain.
5. Do any deviations from the QA
Project Plan affect data quality?
6. Are written and approved current
standard operating procedures
(SOPs) used in the project? If so,
list them and note whether they are
available at the field site. If not,
briefly describe how and where the
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project procedures are documented.
7. Is the anticipated use of the data
known and documented in the QA
Project Plan?
8. What are the critical
measurements? (List under
Comments)
9. Have performance goals for each
critical measurement been
documented clearly and explicitly
in the QA Project Plan?
10. Do the above performance goals
appear to be based on documented
performance criteria or on actual
QC data compiled for the measured
parameter?
11. Are there established procedures
for corrective or response actions
when performance goals (e.g., out-
of-control calibration data) are not
met? If yes, briefly describe them.
12. Are corrective action procedures
consistent with the QA Project
Plan?
13. Have any such corrective actions
been taken during the project?
14. Has the performance of each of the
critical measurements been
assessed and documented during
the project?
15. For each critical measurement,
does the QA Project Plan specify
the frequency of calibration, the
acceptance criteria for the
calibration, and the process for
calibration data reduction and
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review?
16. Briefly describe how calibration
and other QC data are documented.
17. Does the calibration documentation
show that calibrations are being
performed at the required
frequency and in the required
manner?
18. Are there standard paper or
electronic forms to record QC data
and operational data?
19. Are the standard forms dated?
20. Is the person who recorded the data
identified on the form?
21. Are paper records written in
indelible ink?
22. Are the QC data reviewed by
another qualified person such as
the QA manager or the project
manager? Who is this individual?
23. Is the project team adhering to the
planned schedule? If not, explain
the new schedule. Verify that all
schedule changes have been
authorized.
Additional Questions or Comments:

B. ORGANIZATION AND RESPONSIBILITIES

Identify the following personnel and determine whether they have the listed responsibilities.
1. Project Manager:
(name)
$ Responsible for overall
performance of the project, and
$ Communicates with EPA.
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2. Project Quality Assurance

Manager (QAM):
(name)
$ Reviews instrumentation and
QC data, and
$ Performs QC activities.
3. EPA QA Representative:
(name)
$ Assists with and will be
responsible for review and
monitoring of all QA and QC
activities.
4. Project Manager at Site:
(name)
$ Coordinates with project
manager, and
$ Plans and schedules the project.
5. Analytical Instrumentation
Operator(s):
(name)

(name)
$ Operate the instrumentation,
$ Calibrate the instrumentation,
and
$ Record operational parameters.
6. Who is authorized to halt the
project in the event of a health or
safety hazard?
7. Does the project maintain
descriptions of the project
organization and personnel
responsibilities?
Additional Questions or Comments:

C. TRAINING AND SAFETY

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1. Do the instrument operators have

special training or experience for
the operation of the instruments?
2. Do the project files contain current
summaries of the training and
qualifications of project personnel?
3. Is there special safety equipment
required to ensure the health and
safety of project personnel?
4. Is each project team member
appropriately outfitted with safety
gear?
5. Are project personnel adequately
trained for their safety during the
performance of the project?
1. Is there evidence of conditions that
present a clear danger to the health
and safety of project personnel? If
so, take appropriate steps to stop
work or to inform the appropriate
responsible parties of the danger.
Additional Questions or Comments:

D. ANALYTICAL INSTRUMENTATION
1. Describe the analytical
instrumentation. List the brand,
model number, serial number, and
range for each instrument. Do the
instruments use EPA standard
methods?
2. Describe the sampling probe for
the instrumentation.
3. Describe the sampling lines for the
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instrumentation.
4. Does the sample probe have a
calibration valve assembly for
sampling system bias tests?
5. Is the sampling system maintained
according to the prescribed
schedule?
6. Describe the sampling system
filter. Is the filter changed
according to the prescribed
schedule?
7. Describe the sample pump.
8. Describe the sample flow rate
control system. List the sample
flow rate.
9. Describe the sample distribution
manifold.
10. How are data recorded (e.g., the
data acquisition system)? Briefly
describe the system, giving its
brand, model, and serial number.
11. Does the data recording system
have a provision for documenting
changes in operating parameters?
If not, are changes in operating
parameters documented in some
other manner?
12. Is there a hardcopy backup for the
data recording system?
13. Can data be recovered from the
hardcopy backup?
14. Is there a schedule for preventive
maintenance for the
instrumentation?
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15. Are calibration and maintenance
logs kept for the instrumentation?
16. Review the maintenance and
operational records for the
instrumentation. Based on your
findings, do all instruments appear
to be in good operating condition?
17. Are the manufacturer=s operating
manuals readily available to the
instrumentation operators?
18. Describe the routine calibration
procedure.
19. Does the calibration documentation
show that the calibration
procedures are being followed?
20. Do the calibration standards have
the appropriate levels?
21. Are the calibration standards
traceable to standards from the
National Institute of Standards and
Technology (NIST) or to other
accepted standards organizations?
22. What is the instrumentation
calibration error according to the
calibration documentation?
23. What is the instrumentation
linearity error according to the
calibration documentation?
24. What are the instrumentation zero
and calibration drifts according to
the calibration documentation?
25. What is the sampling system bias
according to the calibration
documentation?
26. Do the instruments have any
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interferences? How are the data
corrected for interferences?
27. Are the calibration standards and
delivery system properly
maintained?
Additional Questions or Comments: