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guide the audit. An initial ADQ will be conducted on the first batch of test data within 10 business days of
when data are available to identify errors early in the data reduction process. The first batch is defined as
the testing and variable data generated over the first 2 weeks of testing by the MERC PC. The remaining
data will be audited after all data for a technology has been posted on the project SharePoint site and once
all statistical analyses are complete. The primary focus of this second audit will be the variable data.
Finally, a third ADQ will trace the data from initial acquisition, through reduction and statistical
comparisons, to final presentation in the reports and verification statements. It will also confirm
reconciliation of the two ADQs.
All formulae applied to the data will be verified, and 20% of the calculations will be checked. Data for the
technologies will be reviewed for calculation and transcription errors and data traceability. An audit
report will be prepared as a memo to the MERC PC within 10 business days after completion of each data
audit; the completed checklist will be attached. The MERC Director will be copied on the memo. The
MERC PC will respond to the audit within 10 business days. The MERC QA Manager will verify that all
audit Findings and Observations have been addressed and that corrective actions are appropriately
implemented. A copy of the complete ADQ report with corrective actions will be provided to the MERC
Director within 10 business days after receipt of the audit response.
C.1.4.
QA/QC Reporting
Each assessment and audit will be documented in accordance with Section 3.3.4 of the MERC QMP. The
results of the PEA, including raw data and calculations, will be reported as stated in Section C1.1. The
results of the TSA and ADQ will be submitted to the MERC Director. Assessment reports will include the
following:
•
identification of Findings and Observations;
•
recommendations for resolving problems;
•
response to adverse findings or potential problems;
•
confirmation that solutions have been implemented and are effective;
•
citation of any noteworthy practices that may be of use to others.
C.2.
Reports to Management
During the BWTS evaluation, any deviations from this QAPP or the specific Test Plan will be reported
immediately to the MERC Director. The MERC QA Manager, during the course of any assessment or
audit, will identify to the technical staff performing experimental activities any immediate corrective
action that should be taken. A summary of the required assessments and audits, including a listing of
responsibilities and reporting timeframes, is included in Table 9.
Corrective action procedures for a specific BWTS test depend on the severity of the nonconformance
condition. In cases in which immediate and complete corrective action is implemented by project
personnel, the corrective action will be recorded in the appropriate log book. Non-conformance
conditions which could have an impact on project data quality must be communicated within 24 hours to
the MERC PC and the MERC Director, who is authorized to stop work. These types of issues require a
formal corrective action and root cause analysis. The PIs, or MERC QA Manager, can require laboratory
activities to be limited or discontinued until the corrective action is complete and the non-conformance
issue has been eliminated. Laboratory corrective action procedures are defined in each participating
laboratory’s QA manual and SOPs. The PI at each organization is responsible for verifying that corrective
action is implemented according to internal laboratory policies, this QAPP, and the specific test QA/plan.
The individual laboratory PIs are responsible for investigating and implementing test-level corrective
actions to address errors or deviations in the laboratory.