Quality_Assurance.docx

1. Vision The mission of the United States Army Public Health Center (APHC Provisional) is to be the nation’s premier joint research organization planning and executing registry-based and translational research providing innovative solutions for burn, trauma, and combat casualty care from the point of injury through rehabilitation.

1. Mission

1. Purpose

3.1. This Quality Assurance Surveillance Plan (QASP) is a Government-developed document used to determine if the Contractor's performance meets the performance standards contained in the CONTRACT. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

3.1.1. What will be monitored?

3.1.2. How monitoring will take place.

3.1.3. Who will conduct the monitoring.

3.1.4. How monitoring efforts and results will be documented.

3.2. The Contractor is responsible for implementing and delivering performance that meets CONTRACT standards using its Quality Control Plan (QCP). The QASP provides the structure for the Government's surveillance of the Contractor's performance to assure that it meets CONTRACT standards. It is the Government's responsibility to be objective, fair and consistent in evaluating Contractor performance.

3.3. The QASP is not part of the CONTRACT nor is it intended to duplicate the Contractor's QCP. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on Contractor performance.

3.4. The Government shall provide a copy of the QASP to the Contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the Contractor.

The QASP shall ensure early identification and resolution of performance issues to minimize impact on mission performance.

1. Authorities The authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation (FAR), Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the CONTRACT. This acceptance is to be executed by the Contracting Officer or the Contracting Officer’s Representative (COR).

1. Roles and Responsibilities The following Government personnel shall oversee and coordinate surveillance activities.

5.1. Program / Project Manager

The Program / Project Manager (PM) provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR's performance assessment activities. While the PM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any CONTRACT changes on the Government's behalf.

Assigned PM: TBD

Organization or Agency:

Telephone:

Email:

5.2. Contracting Officer

The Contracting Officer (KO) shall ensure performance of all necessary actions for effective contracting, ensure compliance with the CONTRACT terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also ensure the Contractor receives impartial, fair, and equitable treatment under this CONTRACT, and document the final assessment of the Contractor's performance in the Government Contracting Performance Assessment Reporting System (CPARS).

Assigned KO: TBD

Organization or Agency: USAMRAA

Telephone:

Email:

5.3. Contracting Officer's Representative

The COR is responsible for providing continuous technical oversight of the Contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the Contractor's actual performance. The purpose is to ensure that the Contractor meets the performance standards contained in the CONTRACT. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The QASP is the primary tool for documenting Contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: TBD

Organization or Agency:

Telephone:

5.4. Other Key Government Personnel

This may include performance monitors, inspectors, technical experts, or others who provide information that helps the COR monitor Contractor performance.

The designated technical quality assurance personnel are:

Name: TBD Telephone:

Email:

5.5. Contractor Representatives

The following employees of the Contractor serve as the Contractor's Program Manager and Task Manager for this CONTRACT.

5.5.1. Program Manager

Name:

Telephone:

Email:

5.5.2. Task Manager

0. Other Key Contract Personnel

1. Performance Requirements and Method of Surveillance This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

6.1. Contract Surveillance

The goal of the QASP is to ensure that Contractor performance is effectively monitored and documented. The COR's contribution is their professional, relationships with the KO, PM and the Contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of Contractor performance against CONTRACT requirements. The COR uses the methods contained in this QASP to ensure the Contractor is in compliance with CONTRACT requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the Contractor's performance. Additionally, this QASP is based on the premise that the Contractor, not the Government, is responsible for management and Quality Control (QC)/Quality Assurance (QA) actions to successfully meet the terms of the CONTRACT.

6.2. Surveillance Matrix

6.2.1. The Surveillance Matrix Table 2 on the following page identifies the performance objectives and standards that must be performed by the Contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

6.2.2. Performance objectives define the desired outcomes. Performance Standards define the level of service required under the CONTRACT to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the Contractor's performance as it relates to the performance element standards. The matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of the Contractor’s performance, Table 1 identifies the performance ratings that may be used.

Table 1: Performance Ratings Performance Rating

Criteria

Table 2: Surveillance Matrix

**** Subject to Change by the appointed COR with the approval of Contracting Officer ****

PWS

Performance Standards Inspection

3.1 Objective 1 –

Deliverable: Coordinate with COR for a timely deliverable schedule according to the budgetary/financial deadlines and budgetary/financial phases as defined by the COR.