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National Electronic Disease Surveillance System (NEDSS ...

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<strong>NEDSS</strong> Phase II, Deliverables 1 and 2<br />

QA Roles and Responsibilities<br />

Describe the organizational and functional alignment of the QA staff. Describe the roles<br />

and responsibilities at the management, team leader, and specialist levels.<br />

Processes<br />

Provide an overview of the processes that QA uses to ensure that processes and products<br />

associated with hardware, software, and documentation are monitored, sampled, and<br />

audited to ensure compliance with methodology, policy, and standards.<br />

Peer Review<br />

Commit to QA participation in the peer review process to identify, document, measure,<br />

and eliminate defects in a work product.<br />

Process Review<br />

Describe audit and assessment reviews that ensure that appropriate steps are taken to<br />

carry out activities specified by the project plan. Describe methods by which QA<br />

monitors processes by comparing the actual steps carried out with those in the<br />

documented procedures. Discuss QA's responsibility to provide review data to<br />

management to provide an indication of the quality and status of the project.<br />

Problem Reporting<br />

Describe the role of QA in identifying problems and recommending corrective actions.<br />

Identify the requirement for tasks to include QA in problem reporting and corrective<br />

action functions. Discuss the procedures and formats for the preparation, tracking, and<br />

management involvement in the use of Quality Action Reports (QARs) used in the<br />

program.<br />

QA Escalation Procedure<br />

Describe the QA escalation procedures that bring high-risk or long-standing, unresolved<br />

noncompliance-tracking issues to senior management's attention.<br />

QA Report Formats<br />

Describe the report formats that formally document and transmit information from QA<br />

audits and/or assessment reviews.<br />

Standards<br />

Describe requirement of QA to ensure that standards are identified that establishes the<br />

prescribed methods for development of work products. Also discuss QA's role in<br />

assessing standards for adequacy and applicability.<br />

Tools<br />

Describe the tool sets that QA employs in the conduct of administrative and technical<br />

functions.<br />

PHRG Page 21 of 35 September 28, 2001

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