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Ref. No. [UMCES] CBL 2015-010
ACT VS15-03
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The field tests at the Chesapeake Biological Laboratory, Solomons, MD during March 11-14,
2014
All of the audits included a review of staff, test procedures (sample collection, sample
analysis, data processing, etc.), facilities, and documentation to assure compliance with the ACT
Test Protocols and Standard Operating Procedures (SOPs) for the pH sensor verification.
The TSA of the laboratory tests at HIMB determined that there were several deviations in
the conduct of the tests from the Test Protocols. Minor deviations, such as schedule changes and
the collection of triplicate versus duplicate samples, were documented in laboratory records.
Other deviations from the Test Protocols included deviations in the sequence of test conditions
and dropping one type of burst sampling. These deviations also were documented and
explanations of the rationale for the changes were provided. It was determined that none of the
deviations in the Test Protocols had any effect on data quality for the verification and no
corrective action was required.
The TSA’s’ findings for the two field tests were positive in nature and indicated that
these components of the pH sensor verification were being implemented in a manner consistent
with the Test Protocols and SOPs. All phases of the implementation of the test reviewed during
the TSA were acceptable and performed in a manner consistent with ACT data quality goals.
The overall quality assurance objectives of the test were met.
ACT personnel are well-qualified to implement the verification, and demonstrated
expertise in pertinent procedures. Communication and coordination among all personnel was
frequent and effective. ACT’s internal record keeping and document control is well organized.
The ACT staff understands the need for QC, as shown in the conscientious development and
implementation of a variety of QC procedures.
All samples and instrument measurements were collected, analyzed and cataloged as
described in the Test Protocols and SOPs. For samples transported and analyzed by other
affiliated laboratories, chain-of-custody (COC) protocols were practiced, specifying time, date,
sample location, unique sample number, requested analyses, sampler name, time and date of
transaction between field and laboratory staff, and name of receiving party at the laboratory.
Examination of maintenance and calibration logs provided evidence of recent and suitable
calibration of sampling and analytical equipment.
Audit of Data Quality
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The ACT QA Manager conducted an Audit of Data Quality (ADQ) on
verified data to document the capability of ACT’s data management system (hardcopy and
electronic) to collect, analyze, interpret, and report data as specified in the Test Protocols and
SOPs.. The ADQ involved an examination of data after they have been collected and verified by
ACT personnel. A representative set of no less than 10% of the data on core parameters was
traced in detail from raw data from field and laboratory logs and instrument readouts, data
transcription or transference, data manipulation, data reduction to summary data, data
calculations, and final reported data.
The ADQ determined that ACT’s sample measurement system performed in accordance
with the performance goals specified in the Test Protocols and that the data were accumulated,
transferred, reduced, calculated, summarized, and reported correctly. There is sufficient
documentation of all procedures used in the data collection and analysis to verify that the data
have been collected in accordance with ACT quality objectives.
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