Appendix_A_QASP_(19-June-15).docx

Appendix A: Quality Assurance Surveillance Plan (QASP)

TTIMS/DDCC

Contract: ___________________________ Contractor: __________________________

1.0 PURPOSE

This Quality Assurance Surveillance Plan (QASP) is a Government developed and applied document used to make sure that systematic quality assurance methods are used in the administration of the Performance-Based Acquisition (PBA) standards included in this contract. The intent is to ensure that the Contractor performs in accordance with performance metrics set forth in the contract documents, that the Government receives the quality of services called for in the contract, and that the Government only pays for the acceptable level of services received.

2.0 AUTHORITY

Authority for issuance of this QASP is provided under FAR 37.6 – Performance-Based Acquisition, FAR 46.4 – Government Contract Quality Assurance, and Inspection and Acceptance clause in the contract.

3.0 SCOPE

The Contractor, and not the Government, is responsible for management and quality control actions necessary to meet the quality standards set forth by the contract. The QASP is put in place to provide Government surveillance oversight of the Contractor’s quality control efforts to assure that they are timely, effective and are delivering the results specified in the contract. The QASP is not intended to duplicate or replace the Contractor’s Management Plan. The QASP is intended to support the Contractor’s efforts in developing its plan for maintaining the levels of quality required to be delivered under the terms of the contract.

4.0 GOVERNMENT RESOURCES

Contracting Officer (CO) – The CO ensures performance of all necessary actions for effective contracting, ensures compliance with the terms of the contract and safeguards the interests of the U.S. Government in the contractual relationship. It is the CO that assures that nonconformance’s are identified, and establishes the significance of a nonconformance when considering the acceptability of supplies or services which do not meet contract requirements. The CO is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.

Contracting Officer’s Representative (COR) - An individual designated in writing by the CO to act as his authorized representative to assist in administering a contract. The source and authority for a COR is the Contracting Officer. COR limitations are contained in the written letter of appointment. The COR plays a major role in the monitoring, inspection and acceptance of the services performed under this contract.

Project Officer(s) (POs) – The PO is a U.S Food and Drug Administration (FDA) researcher and is considered a customer. The POs write the research protocols that drive the services to be conducted; therefore, POs are in the best position to evaluate the quality, timeliness, and trustworthiness of research results that are of utmost importance to the FDA.

5.0 METHODS OF QA SURVEILLANCE

The below listed methods of surveillance shall be used in the administration of this QASP. The Performance Based Matrix table describes the methods of surveillance that will be used to monitor the services and deliverables to be provided under the contract.

6.0 IDENTIFIED QA SURVEILLANCE ITEMS

The Performance Based Service Contract items that have been identified for surveillance are listed in the Performance Based Matrix and include the following:

● Review of documentation and procedures.

● Review of records.

● Review of contract requirements.

● Preparation of QASP report and, if applicable, a nonconformance report.

● Input received from POs and DDCC Steering Committee and Sub-Committee

Any nonconformance identified by the COR during the quality assurance surveillance process will be documented and forwarded to the CO for action. The nonconformance will be categorized as critical, major or minor. The CO may issue a nonconformance report to the contractor. If any nonconformance is found, it is the responsibility of the contractor to make all necessary corrections as required by the CO. The CO will determine when the nonconformance has been resolved. If requested by the CO, the COR will follow-up to verify that corrective action(s) has been successfully taken.

7. DOCUMENTATION

In accordance with the SOW, the Contractor’s Quality Assurance Manager shall, in addition to providing documentation to the COR, maintain a complete Quality Assurance file. The file shall contain copies of all reports, evaluations, recommendations, and any actions related to the Government’s performance of the quality assurance function. All such records shall be retained for the life of this contract. The COR will forward these records to the Contracting Officer at termination or completion of the contract.

Quality Assurance Surveillance Plan (QASP)

(Tasks) Performance Standards Acceptable Quality Levels Methods of Surveillance

Solicitation/Award Section C-1.7 & Contractor’s Milestone Plan