QASP.docx

QUALITY ASSURANCE SURVEILLANCE PLAN

For EEG Analysis of Alphavirus Infection

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.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and safeguard the interests of the United States in the contractual relationship. The KO shall also ensure 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.

Assigned KO: TO BE ENTERED AT TIME OF AWARD Organization or Agency: US Army Medical Research Acquisition Activity Phone: TO BE ENETRED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

b. Contracting Officer’s Representative (COR) – The COR will be located at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The COR will be responsible for technical administration of the contract, and shall ensure proper Government surveillance of the contractor’s performance with the assistance of a Contracting Officer’s Technical Representative (COTR). 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. A 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.

Assigned COR:

TO BE ENTERED AT TIME OF AWARD

Title:

TO BE ENTERED AT TIME OF AWARD

Telephone:

TO BE ENTERED AT TIME OF AWARD

Email:

TO BE ENTERED AT TIME OF AWARD

c. Contracting Officer’s Technical Representative (COTR) – There may be one COTR responsible for assisting the COR in technical administration of the contract, and he or she shall assist the COR in ensuring proper Government surveillance of the contractor’s performance. The COTRs shall provide input and documentation for the COR’s quality assurance file. A COTR 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. The COTR is as follows:

Assigned COTR:

TO BE ENTERED AT TIME OF AWARD

Title:

TO BE ENTERED AT TIME OF AWARD

Telephone:

TO BE ENTERED AT TIME OF AWARD

Email:

TO BE ENTERED AT TIME OF AWARD

3. CONTRACTOR REPRESENTATIVE(S):

The following employee(s) of the contractor serve as the contractor’s Program Manager(s) for this contract.

TO BE COMPLETED AT TIME OF AWARD

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 Performance Requirements Summary Matrix, shown in Table 1 below includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Table 1. Performance Standards for EEG Analysis of Alphavirus Infection

Secured transition of all EEG and video data files back to Government without loss or compromise of information Favorable Past Performance Rating

5. METHODS OF QA SURVEILLANCE.

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

· Review of Quarterly Reports (various)

· Review of Annual Reports (various)

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

· PERIODIC INSPECTION. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

· Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

· Performance reporting.

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.

6. 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:

7. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

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 task manager or representative. A CDR template is attached to this QASP.

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.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, quarterly 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 meet with the contractor quarterly to assess performance and shall provide a written assessment.

PERFORMANCE REPORT

1. Contract Number: W81XWH-XX-P-XXXX

2. COR:

3. Date and time of observation:

4. Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.>

Prepared by:

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: W81XWH-XX-P-XXXX

2. TO: (Contractor Task Manager or representative) <insert name>

3. FROM:

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

<Describe in detail. Identify any attachments.>

5. Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < # days after receipt of this

CDR. >

Prepared by:

Received by:

The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.