Basic HTML Version
41
10.2.3.2.
Technical System Audits
A Technical System Audit (TSA) is a qualitative on-site evaluation of sampling and/or measurement
systems associated with a particular BWTS test. The objective of the TSA is to assess and document the
conformance of on-
site testing procedures with the requirements of the QAPP, Test Plan, and associated
SOPs. The TSA may assess test facilities, equipment maintenance and calibration procedures, reporting
requirements, sample collection, analytical activities, and QC procedures. Both laboratory and field
TSAs may be performed.
The MERC QA Manager conducts a TSA at least once during each BWTS test. A TSA checklist based
on the QAPP and Test Plan is prepared by the MERC QA Manager prior to the assessment and reviewed
by the MERC Director. For each TSA, TSA kickoff meeting will be conducted with the MERC testing
team when possible and appropriate so that the team understands the assessment logistics. The meeting
will cover at least the following information:
•
schedule of assessment(s);
•
proper completion of data records;
•
notification to affected parties;
•
specific assessment requirements (personnel lists, equipment lists, and availability of QAPPs);
•
follow-up procedures for corrective action, including debriefing and discussion of possible
resolutions;
•
corrective action guidelines to facilitate completion of the reported assessment.
At the close of the TSA, an immediate informal debriefing will be conducted. A formal debriefing by the
MERC QA Manager to the MERC Director, MERC Program Coordinator, and the on-site team that was
audited, may be conducted when appropriate. The results of TSAs will be documented in a formal audit
report. The TSA report schedule is as follows:
•
The draft TSA report with the completed checklist will be submitted to the MERC Program
Coordinator within 10 days of the TSA.
•
The MERC Program Coordinator’s audit response is due 10 working days from delivery of the
TSA report.
•
The final TSA, with audit responses, is due to the MERC Director within 10 days of receiving the
response.
The final report with the MERC Program Coordinator’s responses accepted by the QA Manager and
approved by the MERC Director will be signed, scanned, and uploaded to the MERC documents and
records archive.
10.2.3.3.
Audit of Data Quality
An Audit of Data Quality (ADQ) is a quantitative evaluation of the BWTS test data. The objective of the
ADQ is to determine if the test data were collected according to the requirements of the QAPP, Test Plan,
and associated SOPs. The ADQ assesses data accuracy, completeness, quality, and traceability.
The ADQ is conducted after data have been 100% verified by the MERC Program Coordinator or
designated project personnel. The MERC QA Manager conducts the ADQ. An ADQ checklist based on
the QAPP and Test Plan is prepared prior to the assessment by the MERC QA Manager. The amount of
data reviewed during the ADQ, and the reporting frequency, is defined in the QAPP and/or Test Plan,
based on the frequency of data reporting, the test duration, and the presence/absence of data quality issues