B08 - Attachment 04 - QASP_Monoclonal Antibodies.docx

Quality Assurance Surveillance Plan Generation of Monoclonal Antibodies (mAbs)

1. Purpose.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored?

· How Monitoring will take place?

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. Government Roles and Responsibilities

a. Contracting Officer (KO) – The 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 assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

b. Contract Specialist (CS) – The CS 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 CS shall also assure that the contractor receives impartial, fair, and equitable treatment under the contract.

c. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

d. Contracting Officer’s Technical Representative (COTR). A COTR is a Government employee who is authorized to monitor the contractor’s performance under the contract, serve as technical liaison between the contractor and the COR, and perform other duties specified in this document. COTRs have no authority to change any of the terms or conditions of the contract.

3. Contractor Representatives. The contractor’s identified employee shall serve as the contractor’s Program Manager and Task Manager for the contract.

4. Performance Standards. Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The below Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). If the performance standards are not met in the performance requirement summary the government will document the contractor’s past performance, and may terminate the contract in accordance with FAR Clause 52.212-4 (m), Termination For Cause.

5. Incentives. The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. Methods of Quality Assurance Surveillance.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's Program Manager and Task Manager when a defect is identified and inform the manager of the specifics of the problem. The COR, with assistance from the CS, shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

a. Direct Observation. Can be performed periodically or through 100% surveillance.

· Periodically

b. Periodic Inspection. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.

· As requested or required.

c. 100% Inspection. Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.

· Provide reports and documentation as specified in the PWS and the Performance Requirements Summary Matrix above.

d. Progress or status meetings.

Surveillance results may be used as the basis for actions (to include payment deductions) against the Contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions

7. Ratings. Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

8. Documenting Performance.

a. Acceptable Performance. The Government shall document positive performance.

b. Unacceptable Performance. When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's Program Manager and Task Manager or on-site representative.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

9. Frequency of Measurement.

a. During contract performance, the COR shall take periodic measurements, as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall assess performance and provide a written assessment, and upload the assessment to Surveillance and Performance Monitoring Module on a monthly basis, no later than the 15th day of the following month.