Basic HTML Version
44
Once the TSA or ADQ report has been prepared, the PC will respond to each Finding or Observation
following the timeline defined in section C1 and will implement any necessary corrective action. The
MERC QA Manager will verify that corrective action has been implemented effectively.
In addition to this QAPP and the specific Test Plan, a final report for each participating vendor and for
each technology verified will be prepared and reviewed. The final report is a comprehensive document
describing the BWTS test and will include all technologies from a particular vendor. Each draft report
will be submitted to the respective vendor for review as well as the expert peer reviewers. Each final
report will be signed by the MERC Director. Original signed reports will be provided to the respective
vendors and posted on the MERC website (www.maritime-enviro.org).
Table 9. Summary of assessment reports
1
.
Assessment
Prepared By
Report Submission Timeframe
Submitted To
TSA
MERC QA Manager TSA response is due to QA
Manager within 10 business days.
TSA responses will be verified by
the QA Manager and provided to
MERC Director within 20
business days.
MERC Director
ADQ 1
(first batch)
MERC QA Manager ADQ will be completed within 10
business days after receipt of first
data set
MERC Director
ADQ 2
(raw data)
MERC QA Manager ADQ will be completed once all
data are received and analyzed
MERC Director
ADQ 3
(synthesized
data and final
report)
MERC QA Manager ADQ will be completed within 10
business days after completion of
the final report review
MERC Director
1
Any QA checklists prepared to guide audits will be provided with the audit report.
D.
DATA VALIDATION AND USABILITY
All data produced under this QAPP will be evaluated to determine the validity of the on-site monitoring
events and the laboratory analyses. Each MERC field and laboratory team member is responsible for
ensuring that all records and results they produce or handle are completely and correctly recorded,
transcribed, and transmitted. They also are responsible for ensuring that all activities performed) comply
with all requirements outlined in this QAPP, the MERC QMP, and relevant SOPs. The MERC is
responsible for final verification and validation of all results.
D.1.
Data Review, Verification, and Validation Requirements
Data review is the in-house examination to ensure that the data have been recorded, transmitted, and
processed correctly. It includes completeness checks to determine if there are any deficiencies such as
missing data or lost integrity. Data verification is the process for evaluating the completeness, correctness,
and conformance / compliance of the data set against method, procedural and contractual specifications.
Data validation is an analyte and sample specific process to determine the quality of a specific data set
relative to the end use.