Attch04BaseQASP22Dec2021.docx

ATTACHMENT 4: QUALITY ASSURANCE SURVEILLANCE PLAN

Solicitation Number: W81XWH21R0078

Original Date: 22 Dec 2021 Revised Date: N/A Title: REGULATED ACTIVITIES SUPPORT Requiring Activity/Agency Name: Office of Regulated Activities (ORA), U.S. Army Medical Research and Development Command (USAMRDC) Program Name: N/A Contract Number: < upon award, enter number>

Contract Description: This contract is for (1) regulatory consultation, (2) regulatory oversight, and (3) Contract Research Organization (CRO) support to include administrative, financial, clinical, nonclinical, manufacturing and regulatory support for drugs, biologics, and devices within an integrated product team framework.

Contractor’s Name: < upon award, enter contractor name > (hereafter referred to as the contractor).

1. PURPOSE.

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

1. What will be monitored.

1. How monitoring will take place.

1. Who will conduct the monitoring.

1. 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.

The following FAR clause applies: FAR 52.212-4 Contract Terms and Conditions-Commercial Items

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 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.

Assigned KO: <to be entered by contracting activity upon award> Organization or Agency: <to be entered by contracting activity upon award> Telephone: <to be entered by contracting activity upon award> Email: <to be entered by contracting activity upon award>

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall ensure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file and record all quality assurance activities in the Wide Area Work Flow Contracting Officer’s Representative Tool system. 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.

Assigned COR: <to be entered by COR upon award> Title: <to be entered by COR upon award> Telephone: <to be entered by COR upon award> Email: <to be entered by COR upon award>

c. Other Key Government Personnel –

Name: <to be entered by COR upon award> Title: <to be entered by COR upon award> Telephone: <to be entered by COR upon award> Email: <to be entered by COR upon award>

3. CONTRACTOR REPRESENTATIVES:

The following employees of the contractor serve as the contractor’s Program Manager and Contract Manager for this contract.

a. Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

b. Contract Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

c. Other Contractor Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title> Telephone: <enter number> Email: <enter address>

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 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).

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 QA 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 task manager or on-site 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.

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.)

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. A report will be generated each month in the Procurement Integrated Enterprise Environment (PIEE) Surveillance and Performance Monitoring (SPM) system. 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 Program or Contracts Manager. 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.

9. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract performance, the COR shall take periodic measurements, as specified in the AQL column of the Performance Requirements 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.

10. REVISIONS.

The QASP is subject to change at any time at the Government’s discretion. The QASP is not incorporated into the contract, therefore changes, if made, do not necessitate a contract modification. However, if there are changes to this QASP, the contractor will be notified promptly and provided a copy of the changes.

Prepared by:

Jami Clevenger Contracting Officer’s Representative

PERFORMANCE REPORT

1. CONTRACT NUMBER: <insert number>

2. Prepared by: (Name of COR) <insert name>

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: <Enter COR’s name>

CONTRACT DISCREPANCY REPORT (CDR):

<This report is to be completed by the COR if a performance issue arises>

1. Contract Number: <insert number>

2. TO: (Program Manager or on-site representative) <insert name>

3. FROM: (Name of COR) <insert name>

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: <insert name>

Received by: