QASP.docx

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Electronic Safety Data Sheet
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Quality Assurance Surveillance Plan for MSDSpro Contract

A. 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.

B. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities:

i. 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 ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

ii. 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 Organization or Agency: US Army Medical Research Institute of Infectious Diseases Phone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

iii. Contracting Officer’s Technical Representative (COTR) – There will 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 Organization or Agency: US Army Medical Research Institute of Infectious Diseases Phone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

C. CONTRACTOR REPRESENTATIVE(S)

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

TO BE ENTERED AT TIME OF AWARD

D. 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).

1. Performance Standards for MSDSpro Inventory Management System

Contract Requirement
Method of Surveillance
Standard
Acceptable Quality Level
Incentive
System is available online 24hrs a day 365 days a year unless outage is coordinated with end-user
100% inspection
No uninterrupted access experienced
Continuous access
Favorable Performance Rating
Outdated SDS’s are replaced as soon as available from manufacturer
100% inspection
SDS is updated within 30 days of new version
Most up-to-date SDS
Favorable Performance Rating
All system features and requirements are functional
100% inspection
System and Database are operational
System functions as expected
Favorable Performance Rating
Contractor shall report contract‐related information in accordance with the Contractor Manpower Reporting (CMR)
100% inspection
Applicable information is submitted annually to the CMR Website.
31 October of each year.
Favorable Performance Rating

E. 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.

1. Review of monthly reports

1. Review of reports submitted at the end of each phase

1. Review of annual reports

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.

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

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

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

1. 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.

F. 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:

EXCEPTIONAL:
Performance significantly exceeds contractual requirements to the Government’s benefit.
SATISFACTORY:
Performance meets contractual requirements.
UNSATISFACTORY:
Performance does not meet contractual requirements.

G. DOCUMENTING PERFORMANCE

i. 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.

ii. 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.

H. FREQUENCY OF MEASUREMENT

i. 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.

ii. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor quarterly (in person and/or by phone) to assess performance and shall provide a written assessment.

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