ACT pH Sensor Verification Protocols, PV12-01
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will be compared to the known pH contained in the PE sample(s), as a means of determining if
the ACT team demonstrated its ability to properly measure pH within established control limits.
Laboratories from the TAC (Dickson, SIO and Pratt, NIST) will submit PE CRMs and
buffers to the ACT team as part of a laboratory-sampling event. The ACT test facility will
measure the standards and establish the laboratories methodological level of accuracy and
precision. The QA Manager will evaluate the results of the PE samples as soon as they are
received from the ACT team. The critical elements for review of PE results include: (1) correct
quantitation of the PE sample; (2) accurate and complete reporting of the results; and (3)
measurement system operation within established control limits for precision and accuracy. If
the accuracy criteria are not met, the laboratory will investigate the cause of the failure and
submit a corrective action report to the QA Manager, Chief Scientist, and ACT Director.
Technical System Audit
A Technical System Audit (TSA) is a thorough, systematic, and qualitative audits
evaluation of sampling and/or measurement systems associated with a Verification test. The
objective of the TSA is to assess and document the conformance of on-site testing procedures
with the requirements of the Verification Protocols, published reference methods, 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 will conduct a TSA at least once during each Verification. A
TSA checklist based on the Verification Protocol is prepared by the QA Manager prior to the
assessment and reviewed by the ACT Chief Scientist. At the close of the TSA, an immediate
informal debriefing will be conducted. 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 ACT Chief
Scientist within 10 days of the TSA.
•
The ACT Chief Scientist’s audit response is due 10 working days from delivery of the
TSA report.
•
The final TSA, with audit responses, is due to the ACT Director within 10 days of
receiving the response.
The final report with the ACT Chief Scientist’s responses accepted by the QA Manager and
approved by the ACT Director will be signed, scanned, and uploaded to the ACT documents and
records archive.
Audit of Data Quality
An Audit of Data Quality (ADQ) is a quantitative evaluation of the Verification test data.
The objective of the ADQ is to determine if the test data were collected according to the
requirements of the Verification Protocols and associated SOPs and whether the data were
accumulated, transferred, reduced, calculated, summarized, and reported correctly. The ADQ
assesses data accuracy, completeness, quality, and traceability.
The ADQ is conducted after data have been 100% verified by the ACT Chief Scientist.
The ACT QA Manager conducts the ADQ. The ADQ entails tracing data through their
