Quality Assurance (QA) Summary Template for

XXXXXX Dataset

(To be used starting Oct. 1, 2015)

Research Effort Title:Inactivation of Bacillus anthracis Spores Deposited on Subway Railcar and other Materials through the Fogging of Sporicidal Liquids
Date:08/18/2017
QAPP Title/Version #/Approval Date: Decontamination of Subway and Other Materials through the Fogging of Sporicidal Liquids/Final version/6/2/15
Research Effort Lead:
Joseph Wood
Supervisor:
Shawn Ryan
SDM Manager:
Eletha Roberts
QA Manager:
Eletha Roberts
  1. Did the Research Effort Lead (or designee) verify the dataset?

Yes / X
No
  1. Were there deviations from the approved QAPP, or other planning documents, that impacted the dataset?

Yes
No / X

If yes, describe:

  1. Were all QA/QC verification checks performed as specified in the QAPP or SOP?

Yes / X
No

Discuss the impact to the reported dataset due to any unacceptable QA/QC results or deviations from the approved QAPP or other planning documents:

  1. Were any QA oversight activities performed (e.g., audit or technical review)?

Yes / X
No

If yes, indicate the type of activity and date performed:

Quality assurance (QA)/quality control (QC) procedures were performed in accordance with the Scientific, Technology, Research, Engineering, and Modeling Support (STREAMS II) Program Quality Management Plan (QMP), Version 3 and the quality assurance project plan (QAPP)(2). The QA/QC procedures and results are summarized below.

All equipment (e.g., pipettes, incubators, pressure sensor, PDI, Vaisala, biological safety cabinets) and monitoring devices (e.g., thermometer, hygrometer) used at the time of the evaluation were verified as being certified, calibrated, or validated.

Inoculation control samples were taken from the spore suspension on the day of testing and serially diluted, plated, and counted to establish the spore density used to inoculate the samples. The spore density levels met the QA target criterion of 1 × 109 CFU/mL (±1 log) for all tests.

Technical Systems Audit

Observations and findings from the technical system audit (TSA) were documented and submitted to the laboratory technical lead for response. TSAs were conducted on July 13 and 14, 2015 to ensure that tests were being conducted in accordance with the appropriate QAPP and QMP. As part of the audit, test procedures were compared to those specified in the QAPP and data acquisition and handling procedures were reviewed. None of the findings of the TSA required corrective action.

Data Quality Audit

At least 10 % of the data acquired during the evaluation were audited. Data were reviewed in five separate batches from August 2015 through July 2016. A QA auditor traced the data from the initial acquisition, through reduction and statistical analysis, to final reporting to ensure the integrity of the reported results. All calculations performed on the data undergoing the audit were verified. Only minor issues were noted with the data, mostly data transcription errors that were corrected.

QA/QC Reporting

Each assessment and audit was documented in accordance with the QAPP and QMP. For these tests, findings were noted (none significant) in the data quality audit, and no follow-up corrective action was necessary. The findings were mostly minor data transcription errors requiring some recalculation of efficacy results, but none were gross errors in recording. QA/QC procedures were performed in accordance with the QAPP.

3Data Review

Records and data generated in the evaluation received a QC/technical review before they were utilized in calculating or evaluating results and prior to incorporation in this report.

09/29/2015Version 1.01